{"id":"buprenorphine-and-naloxone","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":["7 DRUG INTERACTIONS Table 3 Includes clinically significant drug interactions with buprenorphine and naloxone sublingual tablets. Table 3. Clinically Significant Drug Interactions Benzodiazepines or other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments. [see Warnings and Precautions (5.2 , 5.3) ] . If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatment for opioid use disorder [see Warnings and Precautions (5.2) ]. Examples Alcohol, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids. Inhibitors of CYP3A4 Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inhibitors can increase the plasma concentration of buprenorphine, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of buprenorphine and naloxone sublingual tablet is achieved. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the buprenorphine plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , potentially resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to buprenorphine. Intervention: If concomitant use is necessary, consider dosage reduction of buprenorphine and naloxone sublingual tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the buprenorphine and naloxone sublingual tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The concomitant use of buprenorphine and CYP3A4 inducers can decrease the plasma concentration of buprenorphine [see Clinical Pharmacology (12.3) ] , potentially resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to buprenorphine. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the buprenorphine plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both therapeutic effects and adverse reactions and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the buprenorphine and naloxone sublingual tablet dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider buprenorphine and naloxone sublingual tablet dosage reduction and monitor for signs of respiratory depression. Examples: Rifampin, carbamazepine, phenytoin Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Clinical Impact: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are metabolized principally by CYP3A4. Efavirenz, nevirapine, and etravirine are known CYP3A inducers, whereas delavirdine is a CYP3A inhibitor. Significant pharma"],"commonSideEffects":["6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Respiratory and CNS Depression [see Warnings and Precautions (5.2 , 5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Adrenal Insufficiency [see Warnings and Precautions (5.6) ] Opioid Withdrawal [see Warnings and Precautions (5.7 , 5.10) ] Hepatitis, Hepatic Events [see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [see Warnings and Precautions (5.9) ] Orthostatic Hypotension [see Warnings and Precautions (5.16) ] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions (5.17) ] Elevation of Intracholedochal Pressure [see Warnings and Precautions (5.18) ] Adverse events commonly observed with administration of buprenorphine/naloxone are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals at 1-888-827-0616, FDA at 1-800-FDA-1088, or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of buprenorphine and naloxone sublingual tablets was evaluated in 497 opioid-dependent subjects. The prospective evaluation of buprenorphine and naloxone sublingual tablets was supported by clinical trials using buprenorphine tablets without naloxone and other trials using buprenorphine sublingual solutions. In total, safety data were available from 3214 opioid-dependent subjects exposed to buprenorphine at doses in the range used in treatment of opioid addiction. Few differences in adverse event profile were noted between buprenorphine and naloxone sublingual tablets and buprenorphine sublingual tablets or buprenorphine administered as a sublingual solution. The following adverse events were reported to occur by at least 5% of patients in a 4-week study (Table 1). Table 1. Adverse Events ≥5% by Body System and Treatment Group in a 4-week Study N (%) N (%) Body System / Adverse Event (COSTART Terminology) Buprenorphine and Naloxone sublingual tablets 16 mg/day Placebo N=107 N=107 Body as a Whole Asthenia 7 (6.5%) 7 (6.5%) Chills 8 (7.5%) 8 (7.5%) Headache 39 (36.4%) 24 (22.4%) Infection 6 (5.6%) 7 (6.5%) Pain 24 (22.4%) 20 (18.7%) Pain Abdomen 12 (11.2%) 7 (6.5%) Pain Back 4 (3.7%) 12 (11.2%) Withdrawal Syndrome 27 (25.2%) 40 (37.4%) Cardiovascular System Vasodilation 10 (9.3%) 7 (6.5%) Digestive System Constipation 13 (12.1%) 3 (2.8%) Diarrhea 4 (3.7%) 16 (15.0%) Nausea 16 (15.0%) 12 (11.2%) Vomiting 8 (7.5%) 5 (4.7%) Nervous System Insomnia 15 (14.0%) 17 (15.9%) Respiratory System Rhinitis 5 (4.7%) 14 (13.1%) Skin and Appendages Sweating 15 (14.0%) 11 (10.3%) The adverse event profile of buprenorphine was also characterized in the dose-controlled study of buprenorphine solution, over a range of doses in four months of treatment. Table 2 shows adverse events reported by at least 5% of subjects in any dose group in the dose-controlled study. Table 2. Adverse Events (≥ 5%) by Body System and Treatment Group in a 16-week Study Body System/Adverse Event (COSTART Terminology) Buprenorphine Dose Sublingual solution. Doses in this table cannot necessarily be delivered in tablet form, but for comparison purposes: \"Very low\" dose (1 mg solution) would be less than a tablet dose of 2 mg \"Low\" dose (4 mg solution) approximates a 6 mg tablet dose \"Moderate\" dose (8 mg solution) approximates a 12 mg tablet dose \"High\" dose (16 mg solution) approximates a 24 mg tablet dose Very Low (N=184) Low (N=180) Moderate (N=186) High (N=181) Total (N=731) N (%) N (%) N (%) "],"contraindications":["4 CONTRAINDICATIONS Buprenorphine and naloxone sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9) ] . Hypersensitivity to buprenorphine or naloxone. ( 4 )"]},"status":"discontinued","trials":["NCT03492099","NCT02651584","NCT06023459","NCT03616236","NCT03586466","NCT05063201","NCT03002961","NCT03489161","NCT04818086","NCT01908842","NCT03235154","NCT01131273","NCT00723749","NCT01999114","NCT04447287","NCT04219540","NCT00249574","NCT01015066","NCT01637922","NCT03580902","NCT02161354","NCT00539123","NCT01843023","NCT01967641","NCT01903005","NCT06406400","NCT04656899","NCT05108935","NCT01846455","NCT07420283","NCT05594121","NCT02593474","NCT03918850","NCT03711318","NCT02093559","NCT04375033","NCT03715634","NCT03975010","NCT04139213","NCT02496403","NCT04049799","NCT00605033","NCT01690546","NCT00134888","NCT00604188","NCT00595764","NCT01114308","NCT00733720","NCT04212065","NCT03744663"],"aliases":["SUBOXONE® sublingual film"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Buprenorphine and naloxone","companyId":"biodelivery-sciences-international","ecosystem":[],"mechanism":{"drugClass":"","explanation":"1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )","oneSentence":"12.1 Mechanism of Action Buprenorphine and naloxone sublingual tablet contains buprenorphine and naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is an opioid antagonist and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally."},"commercial":null,"references":[],"biosimilars":[],"companyName":"BioDelivery Sciences International","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"Buprenorphine and naloxone","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03492099","phase":"Phase 2","title":"Assessing the Safety of Buprenorphine in People With Sickle Cell Disease","status":"COMPLETED","sponsor":"Johns Hopkins University","isPivotal":false,"enrollment":47,"indication":"Sickle Cell Disease","completionDate":"2022-02-28"},{"nctId":"NCT02651584","phase":"Phase 3","title":"A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable De","status":"COMPLETED","sponsor":"Braeburn Pharmaceuticals","isPivotal":true,"enrollment":428,"indication":"Opioid Use Disorders","completionDate":"2016-11"},{"nctId":"NCT06023459","phase":"Phase 3","title":"Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yih-Ing Hser","isPivotal":true,"enrollment":144,"indication":"Opioid-Related Disorders, Substance-Related Disorders","completionDate":"2026-02-28"},{"nctId":"NCT03616236","phase":"Phase 3","title":"Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment","status":"SUSPENDED","sponsor":"Friends Research Institute, Inc.","isPivotal":true,"enrollment":320,"indication":"Opioid Use","completionDate":"2026-12-30"},{"nctId":"NCT03586466","phase":"NA","title":"Pilot for Improved Office Based Treatment of Opioid-Dependence","status":"UNKNOWN","sponsor":"MedicaSafe, Inc.","isPivotal":false,"enrollment":80,"indication":"Opioid-use Disorder","completionDate":"2020-09"},{"nctId":"NCT05063201","phase":"Phase 2","title":"A Phase 2a Randomized, Single-blind, Placebo-controlled Pilot Study to Evaluate the Impact of Cariprazine (1.5mg) on Cocaine Use in OUD-CocUD Patients on Buprenorphine-naloxone.","status":"COMPLETED","sponsor":"Kyle Kampman","isPivotal":false,"enrollment":26,"indication":"Opioid-use Disorder, Cocaine Use Disorder","completionDate":"2025-12-31"},{"nctId":"NCT03002961","phase":"Phase 1","title":"A Multicenter, Open-Label, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Subjects","status":"COMPLETED","sponsor":"Indivior Inc.","isPivotal":false,"enrollment":48,"indication":"Opioid Use Disorder","completionDate":"2013-10"},{"nctId":"NCT03489161","phase":"EARLY/Phase 1","title":"The Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal","status":"COMPLETED","sponsor":"Virginia Commonwealth University","isPivotal":false,"enrollment":3,"indication":"Drug Overdose, Opioid Withdrawal","completionDate":"2018-08-28"},{"nctId":"NCT04818086","phase":"Phase 1","title":"Phase Ib/2a Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder","status":"COMPLETED","sponsor":"Virginia Commonwealth University","isPivotal":false,"enrollment":18,"indication":"Drug Interaction, Analgesics","completionDate":"2023-04-20"},{"nctId":"NCT01908842","phase":"Phase 3","title":"Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Swi","status":"COMPLETED","sponsor":"Orexo AB","isPivotal":true,"enrollment":759,"indication":"Opioid Dependence, on Agonist Therapy","completionDate":"2014-04"},{"nctId":"NCT03235154","phase":"Phase 4","title":"Bridging Care to HCV Treatment Among Opiate Dependent Patients on Buprenorphine/Naloxone Maintenance Therapy: A Pilot Study of Treating HCV With Epclusa at a Psychiatrist-staffed Outpatient Addiction ","status":"COMPLETED","sponsor":"Community Research Initiative of New England","isPivotal":false,"enrollment":11,"indication":"Hepatitis C, Chronic, Hepatitis C","completionDate":"2019-09-26"},{"nctId":"NCT01131273","phase":"Phase 3","title":"Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors","status":"COMPLETED","sponsor":"University of Pennsylvania","isPivotal":true,"enrollment":68,"indication":"HIV","completionDate":"2013-08"},{"nctId":"NCT00723749","phase":"N/A","title":"Post-marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of 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Development, Inc.","isPivotal":false,"enrollment":23,"indication":"Opioid Use Disorder","completionDate":"2020-11-25"},{"nctId":"NCT04219540","phase":"Phase 4","title":"Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults","status":"COMPLETED","sponsor":"NYU Langone Health","isPivotal":false,"enrollment":675,"indication":"Opioid-use Disorder","completionDate":"2025-02-28"},{"nctId":"NCT00249574","phase":"NA","title":"HCV Treatment of IDUs After Buprenorphine Stabilization","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","isPivotal":false,"enrollment":10,"indication":"Hepatitis C, Heroin Dependence","completionDate":"2006-06"},{"nctId":"NCT01015066","phase":"Phase 4","title":"A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults","status":"WITHDRAWN","sponsor":"State University of New York at Buffalo","isPivotal":false,"enrollment":0,"indication":"Opiate Addiction","completionDate":"2014-06"},{"nctId":"NCT01637922","phase":"Phase 1","title":"Effect of Multiple Dosing With BI 201335 on the Safety, Pharmacokinetics and Pharmacodynamics of Steady-state Methadone and Buprenorphine/Naloxone in Subjects on Stable Addiction Management Therapy","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":34,"indication":"Hepatitis C","completionDate":"2012-11"},{"nctId":"NCT03580902","phase":"Phase 1","title":"A Method to Increase Buprenorphine Treatment Capacity","status":"COMPLETED","sponsor":"CBT4CBT, LLC","isPivotal":false,"enrollment":51,"indication":"Opioid-use Disorder","completionDate":"2022-08-01"},{"nctId":"NCT02161354","phase":"Phase 2","title":"A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study To Determine The Efficacy and Safety of Buprenorphine (as NTC-510 and NTC-510A) in Subjects With Pain Following Surgical Extraction o","status":"TERMINATED","sponsor":"NanoSHIFT LLC","isPivotal":false,"enrollment":52,"indication":"Dental Pain","completionDate":"2016-02"},{"nctId":"NCT00539123","phase":"NA","title":"Drug Counseling and Abstinent-Contingent Take-Home Buprenorphine in Malaysia","status":"COMPLETED","sponsor":"Yale University","isPivotal":false,"enrollment":234,"indication":"Opiate Dependence","completionDate":"2012-08"},{"nctId":"NCT01843023","phase":"Phase 4","title":"Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth","status":"COMPLETED","sponsor":"Friends Research Institute, Inc.","isPivotal":false,"enrollment":288,"indication":"Drug Dependence","completionDate":"2019-07"},{"nctId":"NCT01967641","phase":"Phase 2","title":"Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","isPivotal":false,"enrollment":51,"indication":"Opioid 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Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine","status":"RECRUITING","sponsor":"Eli Lilly and Company","isPivotal":false,"enrollment":465,"indication":"Opioid Use Disorder","completionDate":"2028-02"},{"nctId":"NCT05594121","phase":"Phase 4","title":"A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot (Sublocade®) vs Daily Sublingual Bupreno","status":"UNKNOWN","sponsor":"Royal Victoria Hospital, Canada","isPivotal":false,"enrollment":90,"indication":"Moderate to Severe Opioid Use Disorder","completionDate":"2024-12"},{"nctId":"NCT02593474","phase":"Phase 1","title":"Medication-Assisted Treatment for Youth With Substance Use Disorders","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","isPivotal":false,"enrollment":11,"indication":"Opioid Use Disorder, Opioid 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John Winhusen, PhD","isPivotal":true,"enrollment":140,"indication":"Opioid-Related Disorders, Drug Addiction","completionDate":"2025-01-31"},{"nctId":"NCT03711318","phase":"Phase 3","title":"Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals","status":"TERMINATED","sponsor":"New York State Psychiatric Institute","isPivotal":true,"enrollment":8,"indication":"Heroin Dependence","completionDate":"2021-12-31"},{"nctId":"NCT02093559","phase":"NA","title":"","status":"COMPLETED","sponsor":"San Francisco Department of Public Health","isPivotal":false,"enrollment":63,"indication":"Opioid-Related Disorders, Drug Overdose","completionDate":"2016-12"},{"nctId":"NCT04375033","phase":"Phase 4","title":"CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)","status":"RECRUITING","sponsor":"VA Office of Research and Development","isPivotal":false,"enrollment":952,"indication":"Opioid Use Disorder","completionDate":"2029-05-31"},{"nctId":"NCT03715634","phase":"Phase 1","title":"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Novel Subcutaneous Depot Formulation of Buprenorphine (INDV-6200) in Healthy Volunteers","status":"COMPLETED","sponsor":"Indivior Inc.","isPivotal":false,"enrollment":12,"indication":"Opioid-use Disorder","completionDate":"2018-06-07"},{"nctId":"NCT03975010","phase":"Phase 1","title":"An Open-label, Randomized, Single-dose, Parallel-group Study to Investigate the PK Profile of Single Dose Buprenorphine Transdermal Patch 20 mg Applied for 3 Days, 40 mg for 3 Days and 40 mg for 4 Day","status":"UNKNOWN","sponsor":"Mundipharma (China) Pharmaceutical Co. Ltd","isPivotal":false,"enrollment":45,"indication":"Chronic Pain","completionDate":"2020-03-31"},{"nctId":"NCT04139213","phase":"Phase 2","title":"Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement","status":"UNKNOWN","sponsor":"Lifespan","isPivotal":true,"enrollment":250,"indication":"Opioid-use Disorder","completionDate":"2022-10-01"},{"nctId":"NCT02496403","phase":"NA","title":"Buprenorphine and Substance Abuse Services for Prescription Opioid Dependence","status":"COMPLETED","sponsor":"Kaiser Permanente","isPivotal":false,"enrollment":239,"indication":"Opiate Substitution Treatment","completionDate":"2019-05"},{"nctId":"NCT04049799","phase":"N/A","title":"Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes","status":"COMPLETED","sponsor":"University of Vermont","isPivotal":false,"enrollment":88,"indication":"Opioid-use Disorder, Opioid Withdrawal","completionDate":"2024-02-01"},{"nctId":"NCT00605033","phase":"Phase 4","title":"A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects","status":"COMPLETED","sponsor":"Indivior Inc.","isPivotal":false,"enrollment":241,"indication":"Opiate Dependence, Drug Dependence","completionDate":"2009-05"},{"nctId":"NCT01690546","phase":"Phase 2","title":"An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction","status":"COMPLETED","sponsor":"Paolo Mannelli","isPivotal":false,"enrollment":38,"indication":"Opiate Dependence","completionDate":"2015-02"},{"nctId":"NCT00134888","phase":"NA","title":"The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","isPivotal":false,"enrollment":8,"indication":"Opioid-Related Disorders","completionDate":"2002-11"},{"nctId":"NCT00604188","phase":"Phase 4","title":"A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":188,"indication":"Opiate Dependence, Drug Dependence","completionDate":"2009-12-10"},{"nctId":"NCT00595764","phase":"Phase 4","title":"Counseling for Primary Care Office-based Buprenorphine","status":"COMPLETED","sponsor":"Yale University","isPivotal":false,"enrollment":141,"indication":"Opiate Dependence","completionDate":"2011-02"},{"nctId":"NCT01114308","phase":"Phase 3","title":"A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence","status":"COMPLETED","sponsor":"Titan Pharmaceuticals","isPivotal":true,"enrollment":287,"indication":"Opioid Dependency","completionDate":"2011-05"},{"nctId":"NCT00733720","phase":"Phase 1","title":"Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers","status":"COMPLETED","sponsor":"National Institute on Drug Abuse (NIDA)","isPivotal":false,"enrollment":8,"indication":"Cocaine-related Disorders","completionDate":"2009-01"},{"nctId":"NCT04212065","phase":"Phase 4","title":"Long Acting Subcutaneous Compared to Short Acting Sublingual Buprenorphine Administration in Pregnant and Lactating Women","status":"WITHDRAWN","sponsor":"Ohio State University","isPivotal":false,"enrollment":0,"indication":"Opioid Use Disorder","completionDate":"2020-09-01"},{"nctId":"NCT03744663","phase":"Phase 2","title":"A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films","status":"WITHDRAWN","sponsor":"Wake Forest University Health Sciences","isPivotal":false,"enrollment":0,"indication":"Opioid Use","completionDate":"2022-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"SUBLINGUAL","dosage_text":"2 DOSAGE AND ADMINISTRATION Administer buprenorphine and naloxone sublingual tablet sublingually as a single daily dose. ( 2.1 ) Strongly consider prescribing naloxone at the time buprenorphine and naloxone sublingual tablet is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. ( 2.2 ) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident. After induction, doses of buprenorphine and naloxone sublingual tablets should be progressively adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms ( 2.3 ) The recommended target dosage of buprenorphine and naloxone sublingual tablet for maintenance is 16/4 mg. ( 2.3 ) Administer buprenorphine and naloxone sublingual tablets as directed in the Full Prescribing Information. ( 2.3 , 2.4 ) When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. ( 2.7 ) 2.1 Important Dosage and Administration Information Buprenorphine and naloxone sublingual tablet is administered sublingually as a single daily dose. Buprenorphine and naloxone sublingual tablets should be used in patients who have been initially inducted using buprenorphine sublingual tablets. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. 2.2 Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with buprenorphine and naloxone sublingual tablets. Also consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose [see Warnings and Precautions (5.2) ]. Advise patients and caregivers that naloxone may also be administered for a known or suspected overdose with buprenorphine and naloxone sublingual tablets itself. Higher than normal doses and repeated administration of naloxone may be necessary due to the long duration of action of buprenorphine and naloxone sublingual tablets and its affinity for the mu‐opioid receptor [see Overdosage (10) ]. Inform patients and caregivers of their options for obtaining naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community‐based program) [see Patient Counseling Information (17) ]. 2.3 Maintenance The dosage of buprenorphine and naloxone sublingual tablet should be progressively adjusted in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms. The maintenance dose of buprenorphine and naloxone sublingual tablet is generally in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day depending on the individual patient. The recommended target dosage of buprenorphine and naloxone sublingual tablets is 16 mg/4 mg buprenorphine/naloxone/day as a single daily dose. Dosages higher than 24 mg/6 mg have not been demonstrated to provide any clinical advantage. When determining the prescription quantity for unsupervised administration, consider the patient's level of stability, the security of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medication. There is no maximum r"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Pain"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}