{"id":"en3409","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Application site irritation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"EN3409 leverages BioDelivery Sciences' proprietary BEMA (Buccal Mucosa Adhesive) or similar transmucosal delivery technology to deliver buprenorphine, a partial mu-opioid receptor agonist. This approach aims to improve bioavailability, patient compliance, and potentially reduce diversion risk compared to conventional formulations. Buprenorphine's partial agonist activity at the mu-opioid receptor provides analgesia and opioid dependence treatment with a lower overdose risk profile than full agonists.","oneSentence":"EN3409 is a buprenorphine formulation designed to provide sustained opioid receptor agonism with reduced abuse potential through a specialized delivery technology.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:46:16.990Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe chronic pain"},{"name":"Opioid use disorder (maintenance treatment)"}]},"trialDetails":[{"nctId":"NCT01755546","phase":"PHASE3","title":"Long-term Open-Label Safety Study to Evaluate EN3409","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2012-12","conditions":"Low Back Pain, Osteoarthritis, Neuropathic Pain","enrollment":304},{"nctId":"NCT01633944","phase":"PHASE3","title":"Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2012-08","conditions":"Low Back Pain","enrollment":752},{"nctId":"NCT01871285","phase":"PHASE2","title":"Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2013-06","conditions":"Pain","enrollment":39},{"nctId":"NCT01675167","phase":"PHASE3","title":"Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2012-09","conditions":"Low Back Pain","enrollment":815}],"_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":["Buprenorphine HCI Buccal Film 300-900 mcg twice daily"],"phase":"phase_3","status":"active","brandName":"EN3409","genericName":"EN3409","companyName":"BioDelivery Sciences International","companyId":"biodelivery-sciences-international","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EN3409 is a buprenorphine formulation designed to provide sustained opioid receptor agonism with reduced abuse potential through a specialized delivery technology. Used for Moderate to severe chronic pain, Opioid use disorder (maintenance treatment).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}