{"id":"bnx-sublingual-tablets","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Sweating"},{"rate":null,"effect":"Insomnia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Buprenorphine is a partial mu-opioid receptor agonist that produces analgesia and reduces cravings in opioid use disorder. As a sublingual formulation, it allows rapid absorption through the oral mucosa, bypassing first-pass hepatic metabolism. The partial agonist profile provides a ceiling effect on respiratory depression, making it safer than full opioid agonists.","oneSentence":"BNX is a buprenorphine sublingual tablet that binds to opioid receptors to provide analgesia and opioid dependence treatment.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:56.751Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid use disorder maintenance treatment"},{"name":"Moderate to severe pain"}]},"trialDetails":[{"nctId":"NCT01848054","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence","status":"COMPLETED","sponsor":"Orexo AB","startDate":"2013-06","conditions":"Opioid-Related Disorders, Opiate Dependence","enrollment":313},{"nctId":"NCT01908842","phase":"PHASE3","title":"Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults","status":"COMPLETED","sponsor":"Orexo AB","startDate":"2013-08","conditions":"Opioid Dependence, on Agonist Therapy","enrollment":759},{"nctId":"NCT01903005","phase":"PHASE4","title":"Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence","status":"COMPLETED","sponsor":"Orexo AB","startDate":"2013-07","conditions":"Opioid Dependence, on Agonist Therapy","enrollment":668}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["OX219","Zubsolv"],"phase":"phase_3","status":"active","brandName":"BNX sublingual tablets","genericName":"BNX sublingual tablets","companyName":"Orexo AB","companyId":"orexo-ab","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BNX is a buprenorphine sublingual tablet that binds to opioid receptors to provide analgesia and opioid dependence treatment. Used for Opioid use disorder maintenance treatment, Moderate to severe pain.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}