{"id":"lamotrigine","brandName":"Lamictal","genericName":"lamotrigine","companyId":"gsk","companyName":"GSK","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Lamotrigine (Lamictal), marketed by GSK, is a well-established adjunctive therapy for epilepsy. Its key strength lies in its proven efficacy and long-standing use, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in generic competition following the patent expiry.","enrichmentLevel":3,"visitCount":0,"mechanism":{"target":"5-hydroxytryptamine receptor 3A, Sigma non-opioid intracellular receptor 1, Sodium channel protein type 1 subunit alpha","drugClass":"Anti-epileptic Agent [EPC]"},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by lamotrigine. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by lamotrigine, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring [see Warnings and Precautions (5.1) ]. WARNING: SERIOUS SKIN RASHES See full prescribing information for complete boxed warning. Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: coadministration with valproate. exceeding recommended initial dose of lamotrigine. exceeding recommended dose escalation for lamotrigine. ( 5.1 ) Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related. ( 5.1 )"],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"9924 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"8410 reports"},{"date":"","signal":"SEIZURE","source":"FDA FAERS","actionTaken":"6541 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"6158 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"5926 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"5834 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"5779 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"5571 reports"},{"date":"","signal":"DEPRESSION","source":"FDA FAERS","actionTaken":"4964 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"4549 reports"}],"drugInteractions":[{"drug":"Estrogen-containing oral contraceptive preparations (30 mcg ethinylestradiol and 150 mcg levonorgestrel)","severity":"major","mechanism":"Decreased lamotrigine concentrations due to induction of glucuronidation; decreased levonorgestrel component.","management":"Adjust lamotrigine dosage as necessary.","clinicalEffect":"Decreased lamotrigine concentrations approximately 50%; decrease in levonorgestrel component by 19%."},{"drug":"Carbamazepine","severity":"major","mechanism":"Induction of glucuronidation leading to decreased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed.","clinicalEffect":"Decreased lamotrigine concentration approximately 40%. May increase carbamazepine epoxide levels."},{"drug":"Lopinavir/ritonavir","severity":"major","mechanism":"Induction of glucuronidation leading to decreased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed.","clinicalEffect":"Decreased lamotrigine concentration approximately 50%."},{"drug":"Atazanavir/ritonavir","severity":"moderate","mechanism":"Induction of glucuronidation leading to decreased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed.","clinicalEffect":"Decreased lamotrigine AUC approximately 32%."},{"drug":"Phenobarbital/Primidone","severity":"major","mechanism":"Induction of glucuronidation leading to decreased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed.","clinicalEffect":"Decreased lamotrigine concentration approximately 40%."},{"drug":"Phenytoin","severity":"major","mechanism":"Induction of glucuronidation leading to decreased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed.","clinicalEffect":"Decreased lamotrigine concentration approximately 40%."},{"drug":"Rifampin","severity":"major","mechanism":"Induction of glucuronidation leading to decreased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed.","clinicalEffect":"Decreased lamotrigine AUC approximately 40%."},{"drug":"Valproate","severity":"major","mechanism":"Inhibition of glucuronidation leading to increased lamotrigine concentration.","management":"Monitor lamotrigine levels and adjust dosage as needed. Consider monitoring valproate levels.","clinicalEffect":"Increased lamotrigine concentrations slightly more than 2-fold. Conflicting data on valproate concentrations: 1) mean 25% decrease in valproate concentrations in healthy volunteers, 2) no change in valproate concentrations in controlled clinical trials in patients with epilepsy."}],"commonSideEffects":[{"effect":"dizziness","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"headache","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"diplopia","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"ataxia","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"nausea","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"blurred vision","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"somnolence","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"rhinitis","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"pharyngitis","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"rash","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"vomiting","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"infection","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"fever","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"accidental injury","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"diarrhea","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"abdominal pain","drugRate":"≥10%","_validated":true,"placeboRate":""},{"effect":"tremor","drugRate":"≥10%","_validated":true,"placeboRate":""}],"contraindications":["Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients."],"specialPopulations":{},"discontinuationRates":[{"trial":"premarketing clinical trials","drugArm":"11%","placeboArm":"","commonReason":"rash (3%), dizziness (2.8%), and headache (2.5%)"},{"trial":"premarketing clinical trials","drugArm":"10%","placeboArm":"","commonReason":"rash (4.5%), headache (3.1%), and asthenia (2.4%)"}],"seriousAdverseEvents":[]},"trials":["NCT00043875","NCT02708849","NCT00404248","NCT00272025","NCT01602510","NCT00056277","NCT00224510","NCT00720473","NCT00007670","NCT00177567","NCT01618825","NCT04156035","NCT00305578","NCT02303106","NCT01376180","NCT00243152","NCT05450822","NCT00071747","NCT00835263","NCT00176228","NCT02256124","NCT01888250","NCT00550407","NCT02300051","NCT03831854","NCT00438451","NCT00807989","NCT01888731","NCT02513654","NCT05145608","NCT00618241","NCT04274179","NCT02374567","NCT03116828","NCT06184581","NCT00513019","NCT00485771","NCT01584765","NCT00001478","NCT00296413","NCT00896987","NCT02081287","NCT00223509","NCT00488566","NCT02283801","NCT00068445","NCT01618799","NCT00299793","NCT00355082","NCT04938856"],"indications":{"approved":[{"id":"lamotrigine-epilepsy---adjunctive-therapy","name":"Epilepsy - Adjunctive Therapy","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients aged 2 years and older","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients aged 2 years and older","diagnosticRequired":null,"brandNameForIndication":"Lamictal"},{"id":"lamotrigine-epilepsy---monotherapy","name":"Epilepsy - Monotherapy","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults (aged 16 years and older) with partial-onset seizures","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults (aged 16 years and older) with partial-onset seizures","diagnosticRequired":null,"brandNameForIndication":"Lamictal"},{"id":"lamotrigine-bipolar-disorder---maintenance","name":"Bipolar Disorder - Maintenance Treatment","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients treated for acute mood episodes with standard therapy","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients treated for acute mood episodes with standard therapy","diagnosticRequired":null,"brandNameForIndication":"Lamictal"}],"offLabel":[],"pipeline":[]},"commercial":null,"patents":[{"type":"Method of Use","number":"11596634","applicant":"OWP PHARMACEUTICALS INC","territory":"US","tradeName":"SUBVENITE","expiryDate":"2040-05-29"},{"type":"Method of Use","number":"11612566","applicant":"OWP PHARMACEUTICALS INC","territory":"US","tradeName":"SUBVENITE","expiryDate":"2040-05-29"},{"type":"Formulation","number":"8637512","applicant":"GLAXOSMITHKLINE LLC","territory":"US","tradeName":"LAMICTAL XR","expiryDate":"2029-01-07"}],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT00043875","phase":"Phase 2","title":"A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 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University","isPivotal":false,"enrollment":1,"indication":"Bipolar Depression","completionDate":"2010-01"},{"nctId":"NCT01602510","phase":"Phase 3","title":"A Fixed-Dose Study of Lamotrigine Versus Placebo in the Long Term Prevention of Relapse and/or Recurrence of a Manic, Hypomanic, Mixed or Depressive Episode in Adult Subjects With Bipolar I Disorder","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":265,"indication":"Bipolar Disorder","completionDate":"2015-12"},{"nctId":"NCT00056277","phase":"Phase 3","title":"Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":150,"indication":"Bipolar Disorder","completionDate":"2005-12-14"},{"nctId":"NCT00224510","phase":"Phase 3","title":"A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in th","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":120,"indication":"Bipolar Disorder, Bipolar Depression","completionDate":"2006-09"},{"nctId":"NCT00720473","phase":"NA","title":"Lamotrigine Therapy in the Treatment of Geriatric Bipolar Depression: An Evaluation of Markers of Cerebral Energy Metabolism","status":"COMPLETED","sponsor":"Mclean Hospital","isPivotal":false,"enrollment":69,"indication":"Bipolar Depression","completionDate":"2011-12"},{"nctId":"NCT00007670","phase":"Phase 3","title":"CSP #428 - Treatment of Seizures in the Elderly Population","status":"COMPLETED","sponsor":"US Department of Veterans Affairs","isPivotal":true,"enrollment":720,"indication":"Seizures","completionDate":"2003-03"},{"nctId":"NCT00177567","phase":"Phase 4","title":"Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study","status":"COMPLETED","sponsor":"University of Pittsburgh","isPivotal":false,"enrollment":60,"indication":"Bipolar 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BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy","status":"RECRUITING","sponsor":"Gitte Moos Knudsen","isPivotal":false,"enrollment":550,"indication":"Epilepsy","completionDate":"2031-12-31"},{"nctId":"NCT00071747","phase":"Phase 3","title":"A Multi-Center, Double Blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine Versus Placebo As Add-On Therapy In Schizophrenia","status":"COMPLETED","sponsor":"GlaxoSmithKline","isPivotal":true,"enrollment":176,"indication":"Schizophrenia","completionDate":"2005-01"},{"nctId":"NCT00835263","phase":"Phase 1","title":"Randomized, 2-Way, Crossover, Bioequivalence Study of Lamotrigine 200 mg Tablets and Lamictal® 200 mg Tablets Administered as 1 x 200 mg Tablet in Healthy Subjects Under Fed Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals 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