{"id":"subutex-buprenorphine-hydrochloride-sch-28444","safety":{"commonSideEffects":[{"rate":"~10-20%","effect":"Headache"},{"rate":"~10-15%","effect":"Constipation"},{"rate":"~5-10%","effect":"Nausea"},{"rate":"~5-10%","effect":"Insomnia"},{"rate":"~5-10%","effect":"Sweating"},{"rate":"~5-10%","effect":"Dizziness"},{"rate":"<1% (dose-dependent)","effect":"Respiratory depression"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Buprenorphine binds with high affinity to mu-opioid receptors in the central nervous system but produces only partial agonist activity, meaning it produces a ceiling effect that limits euphoria and overdose risk compared to full opioid agonists. This partial agonism simultaneously suppresses withdrawal symptoms and reduces the reinforcing effects of illicit opioids, making it effective for opioid maintenance therapy and addiction treatment.","oneSentence":"Buprenorphine is a partial mu-opioid receptor agonist that reduces cravings and withdrawal symptoms in opioid use disorder.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:38:14.701Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid use disorder (maintenance treatment and detoxification)"},{"name":"Pain management (off-label use in some jurisdictions)"}]},"trialDetails":[{"nctId":"NCT00605033","phase":"PHASE4","title":"A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2008-03","conditions":"Opiate Dependence, Drug Dependence","enrollment":241}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Subutex, Buprenorphine Hydrochloride, SCH 28444","genericName":"Subutex, Buprenorphine Hydrochloride, SCH 28444","companyName":"Indivior Inc.","companyId":"indivior-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Buprenorphine is a partial mu-opioid receptor agonist that reduces cravings and withdrawal symptoms in opioid use disorder. Used for Opioid use disorder (maintenance treatment and detoxification), Pain management (off-label use in some jurisdictions).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}