{"id":"lasmiditan","rwe":[],"_fda":{"id":"75a13e98-3736-4256-8277-6c05bcaddcf5","abuse":["9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential (HAP) study in recreational poly-drug users (n=58), single oral therapeutic doses (100 and 200 mg) and a supratherapeutic dose (400 mg) of REYVOW were compared to alprazolam (2 mg) (C-IV) and placebo. With all doses of REYVOW, subjects reported statistically significantly higher “drug liking” scores than placebo, indicating that REYVOW has abuse potential. In comparison to alprazolam, subjects who received REYVOW reported statistically significantly lower “drug liking” scores. In the HAP study, euphoric mood occurred to a similar extent with REYVOW 200 mg, REYVOW 400 mg, and alprazolam 2 mg (43-49%). A feeling of relaxation was noted in more subjects on alprazolam (22.6%) than with any dose of REYVOW (7-11%). Phase 2 and 3 studies indicate that, at therapeutic doses, REYVOW produced adverse events of euphoria and hallucinations to a greater extent than placebo. However these events occur at a low frequency (about 1% of patients). Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse."],"set_id":"aea3358c-ff41-4490-9e6d-c7bf7b3de13f","openfda":{"upc":["0300024491083"],"unii":["760I9WM792"],"route":["ORAL"],"rxcui":["2256937","2256943","2256945","2256947"],"spl_id":["75a13e98-3736-4256-8277-6c05bcaddcf5"],"brand_name":["Reyvow"],"spl_set_id":["aea3358c-ff41-4490-9e6d-c7bf7b3de13f"],"package_ndc":["0002-4312-08","0002-4312-61","0002-4312-62","0002-4491-08","0002-4491-61","0002-4491-62"],"product_ndc":["0002-4312","0002-4491"],"generic_name":["LASMIDITAN"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["LASMIDITAN"],"manufacturer_name":["Eli Lilly and Company"],"application_number":["NDA211280"],"is_original_packager":[true]},"version":"15","pregnancy":["8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724. To learn more please call or visit www.migrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of REYVOW in pregnant women. In animal studies, adverse effects on development (increased incidences of fetal abnormalities, increased embryofetal and offspring mortality, decreased fetal body weight) occurred at maternal exposures less than (rabbit) or greater than (rat) those observed clinically (see Data) . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk for preeclampsia and gestational hypertension during pregnancy. Data Animal Data Oral administration of lasmiditan (0, 100, 175, or 250 mg/kg/day) to pregnant rats throughout organogenesis resulted in increases in skeletal variations at the mid and high doses and reduced fetal body weight at the high dose. The high dose was associated with maternal toxicity. At the no-effect dose (100 mg/kg/day) for adverse effects on embryofetal development in rats, plasma exposure (AUC) was approximately 10 times that in humans at the MRHD. Oral administration of lasmiditan (0, 50, 75, or 115 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in malformations (skeletal and visceral), increases in skeletal variations and embryofetal mortality, and decreased fetal body weight at the highest dose tested, which was associated with maternal toxicity. Plasma exposure (AUC) at the no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbits was less than that in humans at the MRHD. Oral administration of lasmiditan (0, 100, 150, or 225 mg/kg/day) to rats throughout pregnancy and lactation resulted in increases in stillbirth and neonatal mortality at the highest dose tested, which was associated with maternal toxicity and delayed parturition. Plasma exposure (AUC) at the no-effect dose (150 mg/kg/day) for adverse effects on pre- and postnatal development was approximately 16 times that in humans at the MRHD."],"dependence":["9.3 Dependence Physical withdrawal was not observed in healthy subjects following abrupt cessation after 7 daily doses of lasmiditan 200 mg or 400 mg."],"description":["11 DESCRIPTION REYVOW (lasmiditan) is a serotonin (5-HT) 1F receptor agonist for oral administration. The chemical name of lasmiditan hemisuccinate is 2,4,6-trifluoro-N-[6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl]benzamide hemisuccinate. It has the empirical formula of C 19 H 18 F 3 N 3 O 2 •0.5[C 4 H 6 O 4 ] and a molecular weight of 436.41 (hemisuccinate). Lasmiditan hemisuccinate has the following structural formula: Lasmiditan hemisuccinate is a white, crystalline powder that is sparingly soluble in water, slightly soluble in ethanol, and soluble in methanol. A 1 mg/mL aqueous solution of lasmiditan hemisuccinate has a pH of 6.8 at ambient conditions. REYVOW 50 mg tablets contain 50 mg lasmiditan (equivalent to 57.824 mg lasmiditan hemisuccinate) and the inactive ingredients as follows: Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate. Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. REYVOW 100 mg tablets contain 100 mg lasmiditan (equivalent to 115.65 mg lasmiditan hemisuccinate) and the inactive ingredients as follows: Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate. Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, red ferric oxide, talc, titanium dioxide. Structural Formula"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied REYVOW (lasmiditan) 50 mg tablets are light gray, oval, film coated, tablets with “L-50” debossed on one side and “4312” on the other. REYVOW (lasmiditan) 100 mg tablets are light purple, oval, film coated, tablets with “L-100” debossed on one side and “4491” on the other. Strengths 50 mg 100 mg Tablet color Light gray Light purple Imprint (debossed) L-50 4312 L-100 4491 Carton of 8 NDC 0002-4312-08 NDC 0002-4491-08 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].","16.1 How Supplied REYVOW (lasmiditan) 50 mg tablets are light gray, oval, film coated, tablets with “L-50” debossed on one side and “4312” on the other. REYVOW (lasmiditan) 100 mg tablets are light purple, oval, film coated, tablets with “L-100” debossed on one side and “4491” on the other. Strengths 50 mg 100 mg Tablet color Light gray Light purple Imprint (debossed) L-50 4312 L-100 4491 Carton of 8 NDC 0002-4312-08 NDC 0002-4491-08"],"spl_medguide":["This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 07/2022 Medication Guide REYVOW ® (RAY-vow) (lasmiditan) tablets, for oral use, CV What is the most important information I should know about REYVOW? Do not drive or operate machinery for at least 8 hours after you take REYVOW, even if you feel well enough. You should not take REYVOW if you cannot wait at least 8 hours between taking REYVOW and driving or operating machinery. What is REYVOW? REYVOW is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. REYVOW is not used as a preventive treatment of migraine. It is not known if REYVOW is safe and effective in children. REYVOW is a federally controlled substance (CV) because it contains lasmiditan that can be abused. Keep REYVOW in a safe place to protect it from theft. Never give your REYVOW to anyone else, because it may harm them. Selling or giving away REYVOW is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. Before you take REYVOW, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have high blood pressure have a low heart rate are allergic to lasmiditan are pregnant or plan to become pregnant. It is not known if REYVOW will harm your unborn baby. Pregnancy Registry : There is a pregnancy registry for pregnant women who take REYVOW. The purpose of this registry is to collect information about the health of you and your baby if you take REYVOW during pregnancy. To learn more call 1-833-464-4724 or visit www.migrainepregnancyregistry.com. You may also talk to your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. It is not known if REYVOW passes into your breastmilk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider will decide if you can take REYVOW with your other medicines. Especially, tell your healthcare provider if you take: propranolol or other medicines that can lower your heart rate any medicines that can increase your blood pressure any medicines that make you sleepy anti-depressant medicines called: selective serotonin reuptake inhibitors (SSRIs) serotonin norepinephrine reuptake inhibitors (SNRIs) tricyclic anti-depressants (TCAs) monoamine oxidase inhibitors (MAOIs) Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine. How should I take REYVOW? Take REYVOW exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider. Take REYVOW tablets by mouth with or without food. Swallow REYVOW tablets whole. Do not split, crush, or chew. Do not take more than one dose in a 24-hour period. If you take REYVOW 50 mg, 100 mg, or 200 mg, and your headache goes away but comes back, you should not take a second dose within 24 hours. Some people who take too many REYVOW tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with REYVOW. You should write down when you have headaches and when you take REYVOW so you can talk to your healthcare provider about how REYVOW is working for you. What should I avoid while taking REYVOW? Do not drive or operate machinery for at least 8 hours after taking REYVOW. You should not drink alcohol or take other medicines that make you drowsy while taking REYVOW. What are the possible side effects of REYVOW? REYVOW can cause serious side effects including: See “ What is the most important information I should know about REYVOW? ” serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using REYVOW, especially if REYVOW is used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma fast heartbeat changes in blood pressure high body temperature tight muscles trouble walking nausea, vomiting, or diarrhea medication overuse headache. Some people who take medicines like REYVOW for the acute treatment of migraine attacks for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with REYVOW. The most common side effects of REYVOW include: dizziness sleepiness numbness feeling tired tingling Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of REYVOW. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Lilly at 1-800-LillyRx (1-800-545-5979). How should I store REYVOW? Store REYVOW at room temperature between 68°F to 77°F (20°C to 25°C). Keep REYVOW and all medicines out of the reach of children. General information about the safe and effective use of REYVOW. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REYVOW for a condition for which it was not prescribed. Do not give REYVOW to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about REYVOW that is written for health professionals. What are the ingredients in REYVOW? Active ingredient: lasmiditan hemisuccinate Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate. Color mixture ingredients: black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. 100 mg tablets also contain red ferric oxide. REYVOW is a registered trademark of Eli Lilly and Company. Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA www.REYVOW.com Copyright © 2019, 2022, Eli Lilly and Company. All rights reserved. For more information go to www.REYVOW.com or call 1-800-LillyRx (1-800-545-5979). REY-0005-MG-20220715"],"geriatric_use":["8.5 Geriatric Use In controlled clinical trials, dizziness occurred more frequently in patients who were at least 65 years of age (19% for REYVOW, 2% for placebo) compared to patients who were less than 65 years of age (14% for REYVOW, 3% for placebo). A larger increase in systolic blood pressure also occurred in patients 65 years of age and older compared to patients who were less than 65 years of age [see Adverse Reactions ( 6.1 )] . Clinical studies of REYVOW did not include sufficient numbers of subjects aged 65 and over to determine whether there is a difference in efficacy in these patients compared to younger subjects. However, in clinical pharmacology studies, no clinically relevant effect on exposure to REYVOW was observed in elderly subjects [see Clinical Pharmacology ( 12.3 )] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20241113","clinical_studies":["14 CLINICAL STUDIES 14.1 Migraine The efficacy of REYVOW in the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials [Study 1 (NCT02439320) and Study 2 (NCT02605174)]. These studies enrolled patients with a history of migraine with and without aura according to the International Classification of Headache Disorders (ICHD-II) diagnostic criteria. Patients were predominantly female (84%), and White (78%), with a mean age of 42 years (range 18-81). Twenty-two percent of patients were taking preventive medication for migraine at baseline. Study 1 randomized patients to REYVOW 100 mg (n=744), or 200 mg (n=745) or placebo (n=742) and Study 2 randomized patients to REYVOW 50 mg (n=750), 100 mg (n=754), or 200 mg (n=750) or placebo (n=751). Patients were allowed to take a rescue medication 2 hours after taking study drug; however, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of study drug administration. The primary efficacy analyses were conducted in patients that treated a migraine with moderate to severe pain within 4 hours of the onset of the attack. The efficacy of REYVOW was established by an effect on pain freedom at 2 hours and Most Bothersome Symptom (MBS) freedom at 2 hours compared to placebo for Studies 1 and 2. Pain freedom was defined as a reduction of moderate or severe headache pain to no pain, and MBS freedom was defined as the absence of the self-identified MBS (photophobia, phonophobia, or nausea). Among patients who selected an MBS, the most commonly selected MBS was photophobia (54%), followed by nausea (24%), and phonophobia (22%). In both studies, the percentage of patients achieving pain freedom and MBS freedom 2 hours after treatment was significantly greater among patients receiving REYVOW at all doses compared to those receiving placebo (see Table 2 ). Table 2: Migraine Efficacy Endpoints after Treatment for Studies 1 and 2 Study 1 Study 2 REYVOW 100 mg REYVOW 200 mg Placebo REYVOW 50 mg REYVOW 100 mg REYVOW 200 mg Placebo Pain Free at 2 hours N 498 503 515 544 523 521 534 % Responders 28.3 31.8 15.3 28.3 31.4 38.8 21.0 Difference from placebo (%) 13 16.5 7.3 10.4 17.8 p -value <0.001 <0.001 0.006 <0.001 <0.001 MBS Free at 2 hours N 464 467 480 502 491 478 509 % Responders 41.2 40.7 29.6 40.8 44.0 48.7 33.2 Difference from placebo (%) 11.6 11.1 7.6 10.8 15.5 p -value <0.001 <0.001 0.014 <0.001 <0.001 Pain relief at 2 hours, defined as a reduction in migraine pain from moderate or severe to mild or none, was also evaluated (see Table 3 ). Table 3: Additional Migraine Efficacy Endpoint after Treatment for Studies 1 and 2 a The analysis of pain relief was descriptive and was not controlled for Type I error. Study 1 Study 2 REYVOW 100 mg REYVOW 200 mg Placebo REYVOW 50 mg REYVOW 100 mg REYVOW 200 mg Placebo Pain Relief at 2 hours a N 498 503 515 544 523 521 534 % Responders 54.0 55.3 40.0 55.9 61.4 61.0 45.1 Difference from placebo (%) 14.0 15.3 10.8 16.3 15.9 Figure 1 presents the percentage of patients achieving migraine pain freedom within 2 hours following treatment in Studies 1 and 2. Figure 1: Percentage of Patients Achieving Migraine Pain Freedom within 2 Hours in Pooled Studies 1 and 2 a The 50 mg arm was only included in Study 2. Figure 2 presents the percentage of patients achieving MBS freedom within 2 hours in Studies 1 and 2. Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Studies 1 and 2 a The 50 mg arm was only included in Study 2. Figure 1 Figure 2 14.2 Effects on Driving Driving performance was assessed at 90 minutes after administration of REYVOW 50 mg, 100 mg, 200 mg, alprazolam 1 mg, and placebo in a randomized, double-blind, placebo- and active-controlled, five-period crossover study in 90 healthy volunteers (mean age 34.9 years) using a computer-based driving simulation. Driving performance was evaluated using a validated threshold established in a population with blood alcohol concentration of 0.05%. The primary outcome measure was the difference from placebo in the Standard Deviation of Lateral Position (SDLP), a measure of driving performance. A dose-dependent impairment of computer-based simulated driving performance was seen with all doses of REYVOW at 90 minutes after administration. Driving performance was also assessed at 8, 12, and 24 hours after administration of REYVOW 100 mg or 200 mg, in a separate randomized, double-blind, placebo- and active-controlled, four-period crossover study in 67 healthy volunteers (mean age 32.8 years) evaluating computer-based simulated driving performance using SDLP as the primary endpoint. Diphenhydramine 50 mg was used as a positive control. The mean SDLP did not reach the threshold for driving impairment at 8 hours or later after administration of REYVOW 100 or 200 mg."],"pharmacodynamics":["12.2 Pharmacodynamics Cardiac Electrophysiology At a dose two times the maximum recommended daily dose, REYVOW does not prolong the QTc interval to any clinically relevant extent."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption Following oral administration, lasmiditan is rapidly absorbed with a median t max of 1.8 hours. In patients with migraine, the absorption or pharmacokinetics of lasmiditan was not different during a migraine attack versus during the interictal period. Effect of Food Coadministration of lasmiditan with a high-fat meal increased the mean lasmiditan C max and AUC values by 22% and 19%, respectively, and delayed the median t max by 1 hour. This difference in exposure is not expected to be clinically significant [see Dosage and Administration ( 2 )] . Lasmiditan was administered without regard to food in clinical efficacy studies. Distribution The human plasma protein binding of lasmiditan is approximately 55% to 60% and independent of concentration between 15 and 500 ng/mL. Elimination Lasmiditan was eliminated with a geometric mean t ½ value of approximately 5.7 hours. No accumulation of lasmiditan was observed with daily dosing. Lasmiditan is primarily eliminated via metabolism, with ketone reduction representing the major pathway. Renal excretion is a minor route of lasmiditan clearance. Metabolism Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes. The following enzymes are not involved in metabolism of lasmiditan: MAO-A, MAO-B, flavin monooxygenase 3, CYP450 reductase, xanthine oxidase, alcohol dehydrogenase, aldehyde dehydrogenase, and aldo-keto reductases. Lasmiditan is also metabolized to M7 (oxidation on piperidine ring) and M18 (combination of M7 and M8 pathways). These metabolites are considered pharmacologically inactive. Excretion Recovery of unchanged lasmiditan in urine was low and accounted for approximately 3% of the dose. Metabolite S-M8 represented approximately 66% of the dose in urine, with the majority of recovery within 48 hours postdose. Specific Populations Age, Sex, Race/Ethnicity, and Body Weight Based on a population pharmacokinetic (PK) analysis, age, sex, race/ethnicity, and body weight did not have a significant effect on the PK (C max and AUC) of lasmiditan. Therefore, no dose adjustments are warranted based on age, sex, race/ethnicity, or body weight. Geriatric Use In a clinical pharmacology study, administration of lasmiditan to subjects 65 years of age or older demonstrated 26% greater exposure in AUC(0-∞) and 21% higher C max , compared to subjects 45 years of age or less. This difference in exposure is not expected to be clinically significant [see Use in Specific Populations ( 8.5 )] . Renal Impairment In a clinical pharmacology study, administration of lasmiditan to subjects with severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) demonstrated 18% greater exposure in AUC(0-∞) and 13% higher C max , compared to subjects with normal renal function. No dose adjustment is required based on renal function. Hepatic Impairment In a clinical pharmacology study, subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B, respectively) demonstrated 11% and 35%, respectively, greater exposure [AUC(0-∞)] to lasmiditan, compared to subjects with normal hepatic function. The C max were higher by 19% and 33%, respectively, for subjects with mild and moderate hepatic impairment. This difference in exposure is not expected to be clinically significant. The use of lasmiditan has not been studied in subjects with severe hepatic impairment [see Use in Specific Populations ( 8.6 )] . Drug Interaction Studies Potential for Lasmiditan to Affect Other Drugs Drug Metabolizing Enzymes Lasmiditan is an in-vitro inhibitor of CYP2D6 but did not significantly inhibit the activity of other CYP450 enzymes. Modeling and simulation of the impact of lasmiditan on the exposure of dextromethorphan, a recognized sensitive CYP2D6 substrate, indicate that lasmiditan is unlikely to exert clinically significant inhibition of CYP2D6. Lasmiditan, M7, S-M8, and [S,R]-M18 are not reversible or time-dependent inhibitors of monoamine oxidase A (MAO-A). Daily dosing of lasmiditan did not alter the PK of midazolam, caffeine, or tolbutamide, which are substrates of CYP3A, CYP1A2, and CYP2C9, respectively. Coadministration of lasmiditan with sumatriptan, propranolol, or topiramate resulted in no clinically meaningful changes in exposure of these medicinal products. Drug Transporters In a drug interaction study in healthy volunteers, co-administration of 200 mg REYVOW with dabigatran (P-gp substrate) increased the systemic exposures, AUC and C max , of dabigatran by 25% and 22%, respectively [see Drug Interactions ( 7.4 )] . Co-administration of 200 mg REYVOW with rosuvastatin (BCRP substrate) did not affect exposures of rosuvastatin. Lasmiditan inhibits OCT1 in-vitro . However, in a drug-drug interaction study with lasmiditan and sumatriptan (OCT1 substrate), no change in sumatriptan PK was observed. Lasmiditan inhibits renal efflux transporters, MATE1 and MATE2-K, in-vitro . Potential for Other Drugs to Affect Lasmiditan Drug Metabolizing Enzymes Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes. Therefore, it is unlikely that CYP inhibitors or inducers will affect lasmiditan pharmacokinetics. Clinical studies of lasmiditan with sumatriptan, propranolol, or topiramate did not show any significant drug interaction potential. Drug Transporters Lasmiditan is a substrate for P-gp in-vitro ."],"adverse_reactions":["6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment [see Warnings and Precautions ( 5.1 )] Central Nervous System Depression [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Medication Overuse Headache [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW. In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200 mg [see Clinical Studies ( 14.1 )] . Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity. The mean age at study entry was 42.4 years (range 18 to 81). Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12 months in a long-term safety study. Of these, 728 patients were exposed to 100 mg or 200 mg for at least 3 months, 361 patients were exposed to these doses for at least 6 months, and 180 patients were exposed to these doses for at least 12 months, all of whom treated at least 2 migraine attacks per month on average. In that study, 14% (148 out of 1,039) in the 200 mg dose group, and 11% (112 out of 991) in the 100 mg dose group withdrew from the trial because of an adverse event. The most common adverse event resulting in discontinuation in the long-term safety study (greater than 2%) was dizziness. Table 1 shows adverse reactions that occurred in at least 2% of patients treated with REYVOW and more frequently than in patients who received placebo in Studies 1 and 2. The most common adverse reactions (at least 5%) were dizziness, fatigue, paresthesia, and sedation. Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2 a Fatigue includes the adverse reaction related terms asthenia and malaise. b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral. c Sedation includes the adverse reaction related term somnolence. Adverse Reaction REYVOW 50 mg N=654 % REYVOW 100 mg N=1265 % REYVOW 200 mg N=1258 % Placebo N=1262 % Dizziness 9 15 17 3 Fatigue a 4 5 6 1 Paresthesia b 3 7 9 2 Sedation c 6 6 7 2 Nausea and/or Vomiting 3 4 4 2 Muscle Weakness 1 1 2 0 Less Common Adverse Reactions The following adverse reactions occurred in less than 2% of REYVOW-treated patients but more frequently than in patients receiving placebo: vertigo, incoordination, lethargy, visual impairment, feeling abnormal, feeling hot or feeling cold, palpitations, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, muscle spasm, limb discomfort, cognitive changes, confusion, euphoric mood, chest discomfort, speech abnormalities, dyspnea, and hallucinations. Hypersensitivity Events of hypersensitivity, including angioedema, rash and photosensitivity reaction, occurred in patients treated with REYVOW. In controlled trials, hypersensitivity was reported in 0.2% of patients treated with REYVOW compared to no patients who received placebo. If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and discontinue administration of REYVOW. Vital Sign Changes Heart Rate Decrease REYVOW was associated with mean decreases in heart rate of 5 to 10 beats per minute (bpm) while placebo was associated with mean decreases of 2 to 5 bpm. Consider evaluating heart rate after administration of REYVOW in patients for whom these changes may not be tolerated, including patients taking other medications that lower heart rate [see Drug Interactions ( 7.3 )] . Blood Pressure Increase REYVOW may increase blood pressure following a single dose. In non-elderly healthy volunteers there was a mean increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of up to 1 mm Hg for placebo. In healthy volunteers over 65 years of age, there was a mean increase from baseline in ambulatory systolic blood pressure of 7 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of 4 mm Hg for placebo. By 2 hours, there were no increases in mean blood pressure with REYVOW compared to placebo. REYVOW has not been well studied in patients with ischemic heart disease. Consider evaluating blood pressure after administration of REYVOW in patients for whom these changes may not be tolerated."],"contraindications":["4 CONTRAINDICATIONS None. None. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS REYVOW may further lower heart rate when administered with heart rate lowering drugs. ( 7.3 ) 7.1 CNS Depressants Concomitant administration of REYVOW and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of REYVOW to cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants [see Warnings and Precautions ( 5.2 )] . 7.2 Serotonergic Drugs Concomitant administration of REYVOW and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John's Wort) that increase serotonin may increase the risk of serotonin syndrome [see Warnings and Precautions ( 5.3 )] . Use REYVOW with caution in patients taking medications that increase serotonin. 7.3 Heart Rate Lowering Drugs REYVOW has been associated with a lowering of heart rate [see Adverse Reactions ( 6.1 )] . In a drug interaction study, addition of a single 200 mg dose of REYVOW to propranolol decreased heart rate by an additional 5 beats per minute compared to propranolol alone, for a mean maximum of 19 beats per minute. Use REYVOW with caution in patients taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern. 7.4 P-glycoprotein (P-gp) Transporter Substrates Coadministration of REYVOW with P-gp substrates where a small change in substrate plasma concentration may lead to serious toxicities (e.g., digoxin) is not recommended [see Clinical Pharmacology ( 12.3 )] ."],"how_supplied_table":["
Strengths
50 mg100 mg
Tablet colorLight grayLight purple
Imprint (debossed)L-50 4312L-100 4491
Carton of 8NDC 0002-4312-08NDC 0002-4491-08
","
Strengths
50 mg100 mg
Tablet colorLight grayLight purple
Imprint (debossed)L-50 4312L-100 4491
Carton of 8NDC 0002-4312-08NDC 0002-4491-08
"],"spl_medguide_table":["
This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: 07/2022
Medication Guide REYVOW® (RAY-vow) (lasmiditan) tablets, for oral use, CV
What is the most important information I should know about REYVOW? Do not drive or operate machinery for at least 8 hours after you take REYVOW, even if you feel well enough.You should not take REYVOW if you cannot wait at least 8 hours between taking REYVOW and driving or operating machinery.
What is REYVOW? REYVOW is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. REYVOW is not used as a preventive treatment of migraine.It is not known if REYVOW is safe and effective in children.REYVOW is a federally controlled substance (CV) because it contains lasmiditan that can be abused. Keep REYVOW in a safe place to protect it from theft. Never give your REYVOW to anyone else, because it may harm them. Selling or giving away REYVOW is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Before you take REYVOW, tell your healthcare provider about all of your medical conditions, including if you: have liver problemshave high blood pressurehave a low heart rateare allergic to lasmiditanare pregnant or plan to become pregnant. It is not known if REYVOW will harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for pregnant women who take REYVOW. The purpose of this registry is to collect information about the health of you and your baby if you take REYVOW during pregnancy. To learn more call 1-833-464-4724 or visit www.migrainepregnancyregistry.com. You may also talk to your healthcare provider about how you can take part in this registry.are breastfeeding or plan to breastfeed. It is not known if REYVOW passes into your breastmilk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider will decide if you can take REYVOW with your other medicines. Especially, tell your healthcare provider if you take: propranolol or other medicines that can lower your heart rateany medicines that can increase your blood pressureany medicines that make you sleepyanti-depressant medicines called:selective serotonin reuptake inhibitors (SSRIs)serotonin norepinephrine reuptake inhibitors (SNRIs)tricyclic anti-depressants (TCAs)monoamine oxidase inhibitors (MAOIs)
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.
How should I take REYVOW? Take REYVOW exactly as your healthcare provider tells you to take it.Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.Take REYVOW tablets by mouth with or without food.Swallow REYVOW tablets whole. Do not split, crush, or chew.Do not take more than one dose in a 24-hour period.If you take REYVOW 50 mg, 100 mg, or 200 mg, and your headache goes away but comes back, you should not take a second dose within 24 hours.Some people who take too many REYVOW tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with REYVOW.You should write down when you have headaches and when you take REYVOW so you can talk to your healthcare provider about how REYVOW is working for you.
What should I avoid while taking REYVOW? Do not drive or operate machinery for at least 8 hours after taking REYVOW.You should not drink alcohol or take other medicines that make you drowsy while taking REYVOW.
What are the possible side effects of REYVOW? REYVOW can cause serious side effects including: See “What is the most important information I should know about REYVOW?”serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using REYVOW, especially if REYVOW is used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:mental changes such as seeing things that are not there (hallucinations), agitation, or comafast heartbeatchanges in blood pressurehigh body temperaturetight musclestrouble walkingnausea, vomiting, or diarrheamedication overuse headache. Some people who take medicines like REYVOW for the acute treatment of migraine attacks for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with REYVOW.
The most common side effects of REYVOW include:
dizzinesssleepinessnumbnessfeeling tiredtingling
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of REYVOW. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Lilly at 1-800-LillyRx (1-800-545-5979).
How should I store REYVOW? Store REYVOW at room temperature between 68°F to 77°F (20°C to 25°C).Keep REYVOW and all medicines out of the reach of children.
General information about the safe and effective use of REYVOW. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REYVOW for a condition for which it was not prescribed. Do not give REYVOW to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about REYVOW that is written for health professionals.
What are the ingredients in REYVOW? Active ingredient: lasmiditan hemisuccinate Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate. Color mixture ingredients: black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide. 100 mg tablets also contain red ferric oxide. REYVOW is a registered trademark of Eli Lilly and Company. Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA www.REYVOW.com Copyright © 2019, 2022, Eli Lilly and Company. All rights reserved. For more information go to www.REYVOW.com or call 1-800-LillyRx (1-800-545-5979).
"],"mechanism_of_action":["12.1 Mechanism of Action Lasmiditan binds with high affinity to the 5-HT 1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT 1F receptor; however, the precise mechanism is unknown."],"controlled_substance":["9.1 Controlled Substance REYVOW contains lasmiditan, a Schedule V controlled substance (CV)."],"storage_and_handling":["16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Lasmiditan binds with high affinity to the 5-HT 1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT 1F receptor; however, the precise mechanism is unknown. 12.2 Pharmacodynamics Cardiac Electrophysiology At a dose two times the maximum recommended daily dose, REYVOW does not prolong the QTc interval to any clinically relevant extent. 12.3 Pharmacokinetics Absorption Following oral administration, lasmiditan is rapidly absorbed with a median t max of 1.8 hours. In patients with migraine, the absorption or pharmacokinetics of lasmiditan was not different during a migraine attack versus during the interictal period. Effect of Food Coadministration of lasmiditan with a high-fat meal increased the mean lasmiditan C max and AUC values by 22% and 19%, respectively, and delayed the median t max by 1 hour. This difference in exposure is not expected to be clinically significant [see Dosage and Administration ( 2 )] . Lasmiditan was administered without regard to food in clinical efficacy studies. Distribution The human plasma protein binding of lasmiditan is approximately 55% to 60% and independent of concentration between 15 and 500 ng/mL. Elimination Lasmiditan was eliminated with a geometric mean t ½ value of approximately 5.7 hours. No accumulation of lasmiditan was observed with daily dosing. Lasmiditan is primarily eliminated via metabolism, with ketone reduction representing the major pathway. Renal excretion is a minor route of lasmiditan clearance. Metabolism Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes. The following enzymes are not involved in metabolism of lasmiditan: MAO-A, MAO-B, flavin monooxygenase 3, CYP450 reductase, xanthine oxidase, alcohol dehydrogenase, aldehyde dehydrogenase, and aldo-keto reductases. Lasmiditan is also metabolized to M7 (oxidation on piperidine ring) and M18 (combination of M7 and M8 pathways). These metabolites are considered pharmacologically inactive. Excretion Recovery of unchanged lasmiditan in urine was low and accounted for approximately 3% of the dose. Metabolite S-M8 represented approximately 66% of the dose in urine, with the majority of recovery within 48 hours postdose. Specific Populations Age, Sex, Race/Ethnicity, and Body Weight Based on a population pharmacokinetic (PK) analysis, age, sex, race/ethnicity, and body weight did not have a significant effect on the PK (C max and AUC) of lasmiditan. Therefore, no dose adjustments are warranted based on age, sex, race/ethnicity, or body weight. Geriatric Use In a clinical pharmacology study, administration of lasmiditan to subjects 65 years of age or older demonstrated 26% greater exposure in AUC(0-∞) and 21% higher C max , compared to subjects 45 years of age or less. This difference in exposure is not expected to be clinically significant [see Use in Specific Populations ( 8.5 )] . Renal Impairment In a clinical pharmacology study, administration of lasmiditan to subjects with severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) demonstrated 18% greater exposure in AUC(0-∞) and 13% higher C max , compared to subjects with normal renal function. No dose adjustment is required based on renal function. Hepatic Impairment In a clinical pharmacology study, subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B, respectively) demonstrated 11% and 35%, respectively, greater exposure [AUC(0-∞)] to lasmiditan, compared to subjects with normal hepatic function. The C max were higher by 19% and 33%, respectively, for subjects with mild and moderate hepatic impairment. This difference in exposure is not expected to be clinically significant. The use of lasmiditan has not been studied in subjects with severe hepatic impairment [see Use in Specific Populations ( 8.6 )] . Drug Interaction Studies Potential for Lasmiditan to Affect Other Drugs Drug Metabolizing Enzymes Lasmiditan is an in-vitro inhibitor of CYP2D6 but did not significantly inhibit the activity of other CYP450 enzymes. Modeling and simulation of the impact of lasmiditan on the exposure of dextromethorphan, a recognized sensitive CYP2D6 substrate, indicate that lasmiditan is unlikely to exert clinically significant inhibition of CYP2D6. Lasmiditan, M7, S-M8, and [S,R]-M18 are not reversible or time-dependent inhibitors of monoamine oxidase A (MAO-A). Daily dosing of lasmiditan did not alter the PK of midazolam, caffeine, or tolbutamide, which are substrates of CYP3A, CYP1A2, and CYP2C9, respectively. Coadministration of lasmiditan with sumatriptan, propranolol, or topiramate resulted in no clinically meaningful changes in exposure of these medicinal products. Drug Transporters In a drug interaction study in healthy volunteers, co-administration of 200 mg REYVOW with dabigatran (P-gp substrate) increased the systemic exposures, AUC and C max , of dabigatran by 25% and 22%, respectively [see Drug Interactions ( 7.4 )] . Co-administration of 200 mg REYVOW with rosuvastatin (BCRP substrate) did not affect exposures of rosuvastatin. Lasmiditan inhibits OCT1 in-vitro . However, in a drug-drug interaction study with lasmiditan and sumatriptan (OCT1 substrate), no change in sumatriptan PK was observed. Lasmiditan inhibits renal efflux transporters, MATE1 and MATE2-K, in-vitro . Potential for Other Drugs to Affect Lasmiditan Drug Metabolizing Enzymes Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes. Therefore, it is unlikely that CYP inhibitors or inducers will affect lasmiditan pharmacokinetics. Clinical studies of lasmiditan with sumatriptan, propranolol, or topiramate did not show any significant drug interaction potential. Drug Transporters Lasmiditan is a substrate for P-gp in-vitro ."],"indications_and_usage":["1 INDICATIONS AND USAGE REYVOW ® is indicated for the acute treatment of migraine with or without aura in adults. REYVOW ® is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use REYVOW is not indicated for the preventive treatment of migraine. ( 1 ) Limitations of Use REYVOW is not indicated for the preventive treatment of migraine."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. ( 5.1 ) Central Nervous System (CNS) Depression: REYVOW may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants. ( 5.2 , 7.1 ) Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with REYVOW. Discontinue REYVOW if symptoms of serotonin syndrome occur. ( 5.3 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.4 ) 5.1 Driving Impairment REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mg doses of REYVOW significantly impaired subjects' ability to drive [see Clinical Studies ( 14.2 )] . Additionally, more sleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not to engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or operating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. 5.2 Central Nervous System Depression REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation [see Adverse Reactions ( 6.1 )] . Because of the potential for REYVOW to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and driving impairment, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants [see Drug Interactions ( 7.1 )] . Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken [see Warnings and Precautions ( 5.1 )] . 5.3 Serotonin Syndrome In clinical trials, reactions consistent with serotonin syndrome were reported in patients treated with REYVOW who were not taking any other drugs associated with serotonin syndrome. Serotonin syndrome may also occur with REYVOW during coadministration with serotonergic drugs [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia, incoordination), and/or gastrointestinal signs and symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue REYVOW if serotonin syndrome is suspected. 5.4 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamines, triptans, opioids, or a combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (i.e., medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary."],"clinical_studies_table":["
Table 2: Migraine Efficacy Endpoints after Treatment for Studies 1 and 2
Study 1Study 2
REYVOW 100 mgREYVOW 200 mgPlaceboREYVOW 50 mgREYVOW 100 mgREYVOW 200 mgPlacebo
Pain Free at 2 hours
N498503515544523521534
% Responders28.331.815.328.331.438.821.0
Difference from placebo (%)1316.57.310.417.8
p-value<0.001<0.0010.006<0.001<0.001
MBS Free at 2 hours
N464467480502491478509
% Responders41.240.729.640.844.048.733.2
Difference from placebo (%)11.611.17.610.815.5
p-value<0.001<0.0010.014<0.001<0.001
","
Table 3: Additional Migraine Efficacy Endpoint after Treatment for Studies 1 and 2
a The analysis of pain relief was descriptive and was not controlled for Type I error.
Study 1Study 2
REYVOW 100 mgREYVOW 200 mgPlaceboREYVOW 50 mgREYVOW 100 mgREYVOW 200 mgPlacebo
Pain Relief at 2 hoursa
N498503515544523521534
% Responders54.055.340.055.961.461.045.1
Difference from placebo (%)14.015.310.816.315.9
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No drug-related tumors were observed following oral administration of lasmiditan to TgRasH2 mice at doses of up to 150 (males) or 250 (females) mg/kg/day for 26 weeks or to rats at doses of up to 75 mg/kg/day for 2 years. Plasma exposures (AUC) at the highest dose tested in rats were approximately 15 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day. Mutagenesis Lasmiditan was negative in in vitro (bacterial reverse mutation, chromosomal aberration in mammalian cells) and in vivo (mouse bone marrow micronucleus) assays. Impairment of Fertility Oral administration of lasmiditan to male (0, 100, 175, or 200 mg/kg/day) or female (0, 100, 150, or 200 mg/kg/day) rats prior to and during mating and continuing in females to Gestation Day 7 resulted in no adverse effects on fertility or reproductive performance. Plasma exposures (AUC) at the highest dose tested (200 mg/kg/day) were approximately 26 times that in humans at the MRHD."],"adverse_reactions_table":["
Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2
a Fatigue includes the adverse reaction related terms asthenia and malaise.
b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral.
c Sedation includes the adverse reaction related term somnolence.
Adverse ReactionREYVOW 50 mg N=654 %REYVOW 100 mg N=1265 %REYVOW 200 mg N=1258 %Placebo N=1262 %
Dizziness915173
Fatiguea4561
Paresthesiab3792
Sedationc6672
Nausea and/or Vomiting3442
Muscle Weakness1120
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Driving Impairment – Advise patients not to engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or operating machinery for at least 8 hours after taking each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW [see Warnings and Precautions ( 5.1 )] . CNS Depression – Inform patients that REYVOW may cause dizziness and sedation. Advise patients to use caution if taking REYVOW in combination with alcohol or other CNS depressants [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.1 )] . Serotonin Syndrome – Caution patients about the risk of serotonin syndrome with the use of REYVOW, particularly during combined use with serotonergic medications such as SSRIs, SNRIs, TCAs, or MAO inhibitors [see Warnings and Precautions ( 5.3 ) and Drug Interactions ( 7.2 )] . Medication Overuse Headache – Inform patients that use of drugs to treat migraine attacks for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions ( 5.4 )] . Hypersensitivity – Advise patients to seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reaction [see Adverse Reactions ( 6.1 )] . Abuse and Dependence – Advise patients that REYVOW is a federally controlled substance because it has the potential to be abused [see Drug Abuse and Dependence ( 9 )] . Advise patients to keep their medication secure. Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations ( 8.1 )] . Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy [see Use in Specific Populations ( 8.1 )] . Nursing Mothers – Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.2 )] . Administration – Advise patients to swallow tablets whole (do not split, crush, or chew) [see Dosage and Administration ( 2 )] . Literature revised September 2022 Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2019, 2022, Eli Lilly and Company. All rights reserved. REY-0007-USPI-20220915"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION The recommended dose of REYVOW is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and REYVOW should not be taken unless the patient can wait at least 8 hours between dosing and driving or operating machinery [see Warnings and Precautions ( 5.1 )] . A second dose of REYVOW has not been shown to be effective for the same migraine attack. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. REYVOW may be taken with or without food. Administer tablets whole; do not split, crush, or chew. The recommended dose is 50 mg, 100 mg, or 200 mg taken orally, as needed. ( 2 ) No more than one dose should be taken in 24 hours. ( 2 , 5.1 ) Administer tablets whole. ( 2 )"],"drug_abuse_and_dependence":["9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance REYVOW contains lasmiditan, a Schedule V controlled substance (CV). 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential (HAP) study in recreational poly-drug users (n=58), single oral therapeutic doses (100 and 200 mg) and a supratherapeutic dose (400 mg) of REYVOW were compared to alprazolam (2 mg) (C-IV) and placebo. With all doses of REYVOW, subjects reported statistically significantly higher “drug liking” scores than placebo, indicating that REYVOW has abuse potential. In comparison to alprazolam, subjects who received REYVOW reported statistically significantly lower “drug liking” scores. In the HAP study, euphoric mood occurred to a similar extent with REYVOW 200 mg, REYVOW 400 mg, and alprazolam 2 mg (43-49%). A feeling of relaxation was noted in more subjects on alprazolam (22.6%) than with any dose of REYVOW (7-11%). Phase 2 and 3 studies indicate that, at therapeutic doses, REYVOW produced adverse events of euphoria and hallucinations to a greater extent than placebo. However these events occur at a low frequency (about 1% of patients). Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse. 9.3 Dependence Physical withdrawal was not observed in healthy subjects following abrupt cessation after 7 daily doses of lasmiditan 200 mg or 400 mg."],"spl_product_data_elements":["Reyvow lasmiditan lasmiditan lasmiditan Microcrystalline cellulose Starch, corn Croscarmellose Sodium Sodium Lauryl Sulfate Magnesium Stearate Polyvinyl Alcohol, Unspecified Titanium dioxide Polyethylene Glycol 3350 Talc Ferrosoferric Oxide light gray oval L50;4312 Reyvow lasmiditan lasmiditan lasmiditan Microcrystalline cellulose Starch, corn Croscarmellose Sodium Sodium Lauryl Sulfate Magnesium Stearate Polyvinyl Alcohol, Unspecified Titanium dioxide Polyethylene Glycol 3350 Talc Ferrosoferric Oxide Ferric Oxide Red light purple L100;4491"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS REYVOW (lasmiditan) tablets are available in two strengths: 50 mg tablet: light gray, oval, film coated, tablets with “L-50” debossed on one side and “4312” on the other 100 mg tablet: light purple, oval, film coated, tablets with “L-100” debossed on one side and “4491” on the other Tablets: 50 mg, 100 mg ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Based on animal data, may cause fetal harm. ( 8.1 ) REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended. ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724. To learn more please call or visit www.migrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of REYVOW in pregnant women. In animal studies, adverse effects on development (increased incidences of fetal abnormalities, increased embryofetal and offspring mortality, decreased fetal body weight) occurred at maternal exposures less than (rabbit) or greater than (rat) those observed clinically (see Data) . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk for preeclampsia and gestational hypertension during pregnancy. Data Animal Data Oral administration of lasmiditan (0, 100, 175, or 250 mg/kg/day) to pregnant rats throughout organogenesis resulted in increases in skeletal variations at the mid and high doses and reduced fetal body weight at the high dose. The high dose was associated with maternal toxicity. At the no-effect dose (100 mg/kg/day) for adverse effects on embryofetal development in rats, plasma exposure (AUC) was approximately 10 times that in humans at the MRHD. Oral administration of lasmiditan (0, 50, 75, or 115 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in malformations (skeletal and visceral), increases in skeletal variations and embryofetal mortality, and decreased fetal body weight at the highest dose tested, which was associated with maternal toxicity. Plasma exposure (AUC) at the no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbits was less than that in humans at the MRHD. Oral administration of lasmiditan (0, 100, 150, or 225 mg/kg/day) to rats throughout pregnancy and lactation resulted in increases in stillbirth and neonatal mortality at the highest dose tested, which was associated with maternal toxicity and delayed parturition. Plasma exposure (AUC) at the no-effect dose (150 mg/kg/day) for adverse effects on pre- and postnatal development was approximately 16 times that in humans at the MRHD. 8.2 Lactation Risk Summary There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production. Excretion of lasmiditan and/or metabolites into milk, at levels approximately 3 times those in maternal plasma, was observed in lactating rats following oral administration of lasmiditan. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for REYVOW and any potential adverse effects on the breastfed infant from REYVOW or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use In controlled clinical trials, dizziness occurred more frequently in patients who were at least 65 years of age (19% for REYVOW, 2% for placebo) compared to patients who were less than 65 years of age (14% for REYVOW, 3% for placebo). A larger increase in systolic blood pressure also occurred in patients 65 years of age and older compared to patients who were less than 65 years of age [see Adverse Reactions ( 6.1 )] . Clinical studies of REYVOW did not include sufficient numbers of subjects aged 65 and over to determine whether there is a difference in efficacy in these patients compared to younger subjects. However, in clinical pharmacology studies, no clinically relevant effect on exposure to REYVOW was observed in elderly subjects [see Clinical Pharmacology ( 12.3 )] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended."],"package_label_principal_display_panel":["PACKAGE LABEL - REYVOW 50 mg 8ct carton NDC 0002-4312-08 8 tablets (2 cards of 4 tablets) REYVOW ® (lasmiditan) CV tablets 50 mg Each tablet contains 50 mg of lasmiditan. Rx only www.REYVOW.com 50 mg Dispense enclosed Medication Guide to each patient. Lilly PDP Text – REYVOW 50 mg 8ct carton","PACKAGE LABEL - REYVOW 100 mg 8ct carton NDC 0002-4491-08 8 tablets (2 cards of 4 tablets) REYVOW ® (lasmiditan) CV tablets 100 mg Each tablet contains 100 mg of lasmiditan. Rx only www.REYVOW.com 100 mg Dispense enclosed Medication Guide to each patient. Lilly PDP Text – REYVOW 100 mg trade carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No drug-related tumors were observed following oral administration of lasmiditan to TgRasH2 mice at doses of up to 150 (males) or 250 (females) mg/kg/day for 26 weeks or to rats at doses of up to 75 mg/kg/day for 2 years. Plasma exposures (AUC) at the highest dose tested in rats were approximately 15 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day. Mutagenesis Lasmiditan was negative in in vitro (bacterial reverse mutation, chromosomal aberration in mammalian cells) and in vivo (mouse bone marrow micronucleus) assays. Impairment of Fertility Oral administration of lasmiditan to male (0, 100, 175, or 200 mg/kg/day) or female (0, 100, 150, or 200 mg/kg/day) rats prior to and during mating and continuing in females to Gestation Day 7 resulted in no adverse effects on fertility or reproductive performance. Plasma exposures (AUC) at the highest dose tested (200 mg/kg/day) were approximately 26 times that in humans at the MRHD."]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"5-hydroxytryptamine receptor 1F","category":"target"},{"label":"HTR1F","category":"gene"},{"label":"N02CC08","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Migraine","category":"indication"},{"label":"Eli Lilly And Co","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Serotonin Agents","category":"pharmacology"},{"label":"Serotonin Receptor Agonists","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":360.489,"date":"","count":149,"signal":"Dizziness","source":"DrugCentral FAERS","actionTaken":"Reported 149 times (LLR=360)"},{"llr":234.838,"date":"","count":81,"signal":"Feeling abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 81 times (LLR=235)"},{"llr":226.261,"date":"","count":60,"signal":"Sedation","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=226)"},{"llr":144.608,"date":"","count":63,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=145)"}],"commonSideEffects":[{"effect":"Dizziness","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Fatigue","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Paresthesia","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Sedation","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Nausea and/or Vomiting","drugRate":"5.4%","severity":"mild","_validated":true},{"effect":"Muscle Weakness","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"Vertigo","drugRate":"reported","severity":"unknown"},{"effect":"Incoordination","drugRate":"reported","severity":"unknown"},{"effect":"Lethargy","drugRate":"reported","severity":"unknown"},{"effect":"Visual Impairment","drugRate":"reported","severity":"unknown"},{"effect":"Feeling Abnormal","drugRate":"reported","severity":"unknown"},{"effect":"Feeling Hot or Feeling Cold","drugRate":"reported","severity":"unknown"},{"effect":"Palpitations","drugRate":"reported","severity":"unknown"},{"effect":"Anxiety","drugRate":"reported","severity":"unknown"},{"effect":"Tremor","drugRate":"reported","severity":"unknown"},{"effect":"Restlessness","drugRate":"reported","severity":"unknown"},{"effect":"Sleep Abnormalities","drugRate":"reported","severity":"unknown"},{"effect":"Muscle Spasm","drugRate":"reported","severity":"unknown"},{"effect":"Limb Discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Cognitive Changes","drugRate":"reported","severity":"unknown"},{"effect":"Confusion","drugRate":"reported","severity":"unknown"},{"effect":"Euphoric Mood","drugRate":"reported","severity":"unknown"},{"effect":"Chest Discomfort","drugRate":"reported","severity":"unknown"},{"effect":"Speech Abnormalities","drugRate":"reported","severity":"unknown"},{"effect":"Dyspnea","drugRate":"reported","severity":"unknown"},{"effect":"Hallucinations","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Pregnancy":"Based on animal data, may cause fetal harm. There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy. There are no adequate data on the developmental risk associated with the use of REYVOW in pregnant women. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for REYVOW and the risk of adverse effects on the breastfed infant from REYVOW.","Geriatric use":"In controlled clinical trials, dizziness occurred more frequently in patients who were at least 65 years of age (19% for REYVOW, 2% for placebo) compared to patients who were less than 65 years of age (14% for REYVOW, 3% for placebo). larger increase in systolic blood pressure also occurred in patients 65 years of age and older compared to patients who were less than 65 years of age","Paediatric use":"Safety and effectiveness in pediatric patients have not been established.","Hepatic impairment":"REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended."}},"trials":[],"aliases":[],"company":"Eli Lilly","patents":[{"applNo":"N211280","source":"FDA Orange Book","status":"Active","expires":"Feb 17, 2028","useCode":"U-1719","territory":"US","drugProduct":true,"patentNumber":"7423050","drugSubstance":true},{"applNo":"N211280","source":"FDA Orange Book","status":"Active","expires":"Jul 7, 2030","useCode":"U-2718","territory":"US","drugProduct":false,"patentNumber":"12257246","drugSubstance":false},{"applNo":"N211280","source":"FDA Orange Book","status":"Active","expires":"Dec 5, 2037","useCode":"U-1719","territory":"US","drugProduct":true,"patentNumber":"11053214","drugSubstance":true},{"applNo":"N211280","source":"FDA Orange Book","status":"Active","expires":"Jul 6, 2040","useCode":"","territory":"US","drugProduct":true,"patentNumber":"12071423","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LASMIDITAN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:44:33.325786+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T02:44:29.945615+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Lasmiditan","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T02:44:40.163870+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:44:38.799086+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T02:44:33.403398+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LASMIDITAN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:44:39.132402+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:44:28.538505+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:44:28.538527+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Serotonin 1f (5-HT1f) receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:44:40.163843+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3039520/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:44:39.826018+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA211280","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:44:28.538532+00:00"}},"allNames":"reyvow","offLabel":[],"synonyms":["lasmiditan","lasmiditan succinate","COL-144","LY-573144","reyvow","rayvow"],"timeline":[{"date":"2019-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ELI LILLY AND CO to Eli Lilly And Co"},{"date":"2019-11-10","type":"positive","source":"DrugCentral","milestone":"FDA approval (Eli Lilly And Co)"},{"date":"2022-01-20","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Eli Lilly Japan K.K.)"},{"date":"2022-08-17","type":"positive","source":"DrugCentral","milestone":"EMA approval (Eli Lilly Nederland B.V.)"},{"date":"2028-02-17","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 7423050 expires"},{"date":"2037-12-05","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 11053214 expires"}],"aiSummary":"Reyvow (Lasmiditan) is a small molecule developed by Eli Lilly and Co, targeting the 5-hydroxytryptamine receptor 1F. It is FDA-approved for the treatment of migraine, with a commercial status as a patented product. Key safety considerations include potential effects on heart rate and blood pressure. Reyvow works by binding to the 5-HT1F receptor, which is involved in the transmission of pain signals. It is not a triptan, but rather a distinct class of medication.","approvals":[{"date":"2019-11-10","orphan":false,"company":"ELI LILLY AND CO","regulator":"FDA"},{"date":"2022-01-20","orphan":false,"company":"ELI LILLY JAPAN K.K.","regulator":"PMDA"},{"date":"2022-08-17","orphan":false,"company":"Eli Lilly Nederland B.V.","regulator":"EMA"}],"brandName":"Reyvow","ecosystem":[{"indication":"Migraine","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"almotriptan","slug":"almotriptan","company":"Janssen Pharms"},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"dihydroergotamine","slug":"dihydroergotamine","company":"Valeant"}],"globalPrevalence":1000000000}],"mechanism":{"target":"5-hydroxytryptamine receptor 1F","novelty":"Follow-on","targets":[{"gene":"HTR1F","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1F","protein":"5-hydroxytryptamine receptor 1F"}],"modality":"Small Molecule","explanation":"Lasmiditan binds with high affinity to the 5-HT1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT1F receptor; however, the precise mechanism is unknown.","oneSentence":"Reyvow works by binding to the 5-HT1F receptor, blocking pain signals in the brain.","technicalDetail":"Lasmiditan acts as a selective agonist of the 5-HT1F receptor, modulating the transmission of pain signals in the trigeminal nucleus caudalis and other areas of the brain involved in migraine pathophysiology."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lasmiditan","title":"Lasmiditan","extract":"Lasmiditan, sold under the brand name Reyvow, is a medication used to treat migraines. It is not useful for prevention. The drug is taken by mouth.","wiki_history":"==History==\nLasmiditan was discovered by Eli Lilly and Company and was then relicensed to CoLucid Pharmaceuticals in 2006, until CoLucid was bought by Eli Lilly in 2017, to allow Eli Lilly to reacquire the drug's intellectual property. The drug is protected by patents until 2031.\n\nPhase II clinical trials for dose finding purposes were completed in 2007, for an intravenous form and in early 2010, for an oral form. Eli Lilly submitted a new drug application to the U.S. Food and Drug Administration (FDA) in November 2018.\n\nThree phase III clinical trials were completed. The SPARTAN trial compared placebo with 50, 100, and 200 mg of lasmiditan. SAMURAI compared placebo with 100 and 200 mg doses of lasmiditan. GLADIATOR is an open-label study that compared 100 and 200 mg doses of lasmiditan in subjects that received the drug as part of a prior trial.\n\nTopline results from the SPARTAN trial showed that the drug induced met its primary and secondary endpoints in the trial. The primary result showed a statistically significant improvement in pain relief relative to placebo 2 hours after the first dose. The secondary result showed a statistically significantly greater percentage of subjects were free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose.\n\nThe FDA approved lasmiditan primarily based on data from two clinical trials, Trial 1 (# NCT02439320) and Trial 2 (#NCT02605174) of 4439 subjects with migraine headaches with or without aura. It was placed into Schedule V in January 2020.","wiki_society_and_culture":"==Society and culture==\n===Regulatory approval===\nOn 23 June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rayvow, intended for the treatment of migraine. Rayvow was approved for medical use in the European Union in August 2022.\n\nLasmiditan has not been approved for use in Canada. The drug sponsor in Canada, Eli Lilly Canada Inc., filed a New Drug Submission in February 2020 but cancelled the submission before a final decision was issued by Health Canada. Health Canada had completed their review of the submission and did not find any deficiencies in the data packages provided in the submission. However, Health Canada and Eli Lilly could not come to agreement on the interpretation of the cardiovascular data and how it would be worded in the product monograph. The drug sponsor cancelled their submission on 26 January 2021 before Health Canada issued a final decision.\n\n===Legal status===\n====United States====\nLasmiditan is a Schedule V controlled substance in the United States. This was based on lasmiditan producing reinforcing effects in a self-administration assay in rodents and increasing drug-liking scores more than placebo but less than the benzodiazepine alprazolam as well as producing euphoric mood in humans. Other effects in humans included somnolence and feeling drunk. Misuse-related adverse effects occurred at a low but significant frequency (~1%) in clinical trials."},"commercial":{"launchDate":"2019","_launchSource":"DrugCentral (FDA 2019-11-10, ELI LILLY AND CO)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5351","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LASMIDITAN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LASMIDITAN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lasmiditan","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T12:16:04.912774","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T02:44:43.602839+00:00","fieldsConflicting":5,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"sumatriptan","drugSlug":"sumatriptan","fdaApproval":"1992-12-28","patentExpiry":"May 9, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"naratriptan","drugSlug":"naratriptan","fdaApproval":"1998-02-10","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"zolmitriptan","drugSlug":"zolmitriptan","fdaApproval":"1997-11-25","genericCount":18,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"rizatriptan","drugSlug":"rizatriptan","fdaApproval":"1998-06-29","patentExpiry":"Jul 30, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"almotriptan","drugSlug":"almotriptan","fdaApproval":"2001-05-07","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"eletriptan","drugSlug":"eletriptan","fdaApproval":"2002-12-26","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"frovatriptan","drugSlug":"frovatriptan","fdaApproval":"2001-11-08","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"lasmiditan","indications":{"approved":[{"name":"Migraine","source":"DrugCentral","snomedId":37796009,"regulator":"FDA","eligibility":"adults","usPrevalence":39000000,"globalPrevalence":1000000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Neurology, 2023"}],"offLabel":[],"pipeline":[]},"currentOwner":"Eli Lilly And Co","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"sumatriptan","brandName":"sumatriptan","genericName":"sumatriptan","approvalYear":"1992","relationship":"same-class"},{"drugId":"naratriptan","brandName":"naratriptan","genericName":"naratriptan","approvalYear":"1998","relationship":"same-class"},{"drugId":"zolmitriptan","brandName":"zolmitriptan","genericName":"zolmitriptan","approvalYear":"1997","relationship":"same-class"},{"drugId":"rizatriptan","brandName":"rizatriptan","genericName":"rizatriptan","approvalYear":"1998","relationship":"same-class"},{"drugId":"almotriptan","brandName":"almotriptan","genericName":"almotriptan","approvalYear":"2001","relationship":"same-class"},{"drugId":"eletriptan","brandName":"eletriptan","genericName":"eletriptan","approvalYear":"2002","relationship":"same-class"},{"drugId":"frovatriptan","brandName":"frovatriptan","genericName":"frovatriptan","approvalYear":"2001","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04396236","phase":"PHASE3","title":"A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine","status":"TERMINATED","sponsor":"Eli Lilly and Company","startDate":"2020-06-15","conditions":["Migraine"],"enrollment":851,"completionDate":"2025-11-12"},{"nctId":"NCT04396574","phase":"PHASE3","title":"A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine","status":"TERMINATED","sponsor":"Eli Lilly and Company","startDate":"2020-06-30","conditions":["Migraine"],"enrollment":566,"completionDate":"2025-12-04"},{"nctId":"NCT05903040","phase":"","title":"Ditan Acute tReatments: Effectiveness and Tolerability (DART)","status":"COMPLETED","sponsor":"University of Florence","startDate":"2023-06-15","conditions":["Migraine","Migraine With Aura","Migraine Without Aura","Chronic Migraine"],"enrollment":100,"completionDate":"2025-12-01"},{"nctId":"NCT07103694","phase":"","title":"i-NEED: NEw migrainE Drugs Database","status":"RECRUITING","sponsor":"IRCCS San Raffaele Roma","startDate":"2022-03-24","conditions":["Episodic Migraine","Chronic Migraine","Medication Overuse Headache"],"enrollment":2641,"completionDate":"2025-12-31"},{"nctId":"NCT06267664","phase":"","title":"Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP)","status":"UNKNOWN","sponsor":"Hospital Clínico Universitario de Valladolid","startDate":"2023-12-04","conditions":["Migraine","Migraine Disorders","Migraine With Aura","Headache Disorders"],"enrollment":1500,"completionDate":"2024-12-01"},{"nctId":"NCT04749914","phase":"PHASE1","title":"A Study of Lasmiditan in Healthy Volunteers","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2021-02-15","conditions":["Healthy"],"enrollment":97,"completionDate":"2021-07-06"},{"nctId":"NCT04881747","phase":"PHASE1","title":"A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2021-05-14","conditions":["Healthy"],"enrollment":47,"completionDate":"2021-07-24"},{"nctId":"NCT03670810","phase":"PHASE3","title":"A Study of Lasmiditan (LY573144) Over Four Migraine Attacks","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-06-24","conditions":["Migraine"],"enrollment":1633,"completionDate":"2021-07-08"},{"nctId":"NCT04081324","phase":"PHASE1","title":"A Study of Lasmiditan in Healthy Chinese Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-11-13","conditions":["Healthy"],"enrollment":36,"completionDate":"2020-06-15"},{"nctId":"NCT03962738","phase":"PHASE2","title":"A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-05-31","conditions":["Migraine"],"enrollment":846,"completionDate":"2020-06-08"},{"nctId":"NCT04218162","phase":"PHASE3","title":"Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in Korean","status":"COMPLETED","sponsor":"IlDong Pharmaceutical Co Ltd","startDate":"2020-03-24","conditions":["Acute Migraine"],"enrollment":294,"completionDate":"2020-10-30"},{"nctId":"NCT03988088","phase":"PHASE1","title":"A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-07-22","conditions":["Migraine"],"enrollment":18,"completionDate":"2020-02-24"},{"nctId":"NCT02565186","phase":"PHASE3","title":"An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2015-10-07","conditions":["Migraine Disorders"],"enrollment":2171,"completionDate":"2019-08-20"},{"nctId":"NCT03465436","phase":"PHASE1","title":"A Study of Lasmiditan on the Heart in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2011-09-16","conditions":["Healthy"],"enrollment":56,"completionDate":"2011-12-20"},{"nctId":"NCT03459612","phase":"PHASE1","title":"A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-03-26","conditions":["Healthy"],"enrollment":68,"completionDate":"2018-06-23"},{"nctId":"NCT03252015","phase":"PHASE1","title":"A Study of Multiple Doses of Lasmiditan in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-08-15","conditions":["Healthy"],"enrollment":70,"completionDate":"2018-01-02"},{"nctId":"NCT03286218","phase":"PHASE1","title":"A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-09-15","conditions":["Recreational Drug Use","Prescription Drug Abuse (Not Dependent)"],"enrollment":96,"completionDate":"2017-11-20"},{"nctId":"NCT03040362","phase":"PHASE1","title":"Absorption, Metabolism and Excretion of [14C]-Lasmiditan - Single Oral Dose Administration","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-04-20","conditions":["Healthy"],"enrollment":8,"completionDate":"2017-05-06"},{"nctId":"NCT03012334","phase":"PHASE1","title":"The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-01-16","conditions":["Migraine"],"enrollment":90,"completionDate":"2017-06-08"},{"nctId":"NCT03182920","phase":"PHASE1","title":"A Study of Lasmiditan in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-06-16","conditions":["Healthy"],"enrollment":35,"completionDate":"2017-08-14"},{"nctId":"NCT00883051","phase":"PHASE2","title":"Dose-ranging Study of Oral COL-144 in Acute Migraine Treatment","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2009-07","conditions":["Migraine Disorders"],"enrollment":512,"completionDate":"2010-02"},{"nctId":"NCT03270644","phase":"PHASE1","title":"A Study of Lasmiditan and Propranolol in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-08-31","conditions":["Healthy"],"enrollment":44,"completionDate":"2017-11-22"},{"nctId":"NCT02439320","phase":"PHASE3","title":"Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:","status":"COMPLETED","sponsor":"Eli Lilly and Company","isPivotal":true,"startDate":"2015-04","conditions":["Acute Migraine"],"enrollment":2231,"completionDate":"2016-08"},{"nctId":"NCT03076970","phase":"PHASE1","title":"Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and 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