{"id":"bema-fentanyl","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Respiratory depression"}]},"_chembl":{"chemblId":"CHEMBL1201159","moleculeType":"Small molecule","molecularWeight":"372.94"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BEMA (BioErodible MucoAdhesive) technology allows fentanyl to be absorbed through the buccal mucosa, bypassing first-pass hepatic metabolism and enabling faster onset compared to oral formulations. Fentanyl acts as a mu-opioid receptor agonist, binding to opioid receptors in the central nervous system to produce analgesia and pain relief.","oneSentence":"BEMA Fentanyl is a fentanyl formulation delivered via a buccal mucoadhesive patch that provides rapid opioid analgesia for breakthrough pain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:57.245Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Breakthrough pain in opioid-tolerant cancer patients"}]},"trialDetails":[{"nctId":"NCT00293033","phase":"PHASE3","title":"Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2006-02","conditions":"Pain, Cancer","enrollment":152},{"nctId":"NCT00696137","phase":"PHASE3","title":"Long-term Extension Study of BEMA™ Fentanyl","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2008-06","conditions":"Respiratory Depression","enrollment":5},{"nctId":"NCT00293020","phase":"PHASE3","title":"Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy","status":"COMPLETED","sponsor":"BioDelivery Sciences International","startDate":"2006-02","conditions":"Pain, Cancer","enrollment":244}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["bioerodible mucoadhesive","fentanyl buccal soluble film","ONSOLIS","bioerodible mucoadhesive system"],"phase":"phase_3","status":"active","brandName":"BEMA Fentanyl","genericName":"BEMA Fentanyl","companyName":"BioDelivery Sciences International","companyId":"biodelivery-sciences-international","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BEMA Fentanyl is a small molecule that acts as a mu opioid receptor agonist, classified as an agonist. It is used to treat conditions such as respiratory depression, pain, and cancer, specifically breakthrough cancer pain.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2009-07-16T00:00:00.000Z","mah":"ADALVO","brand_name_local":"ONSOLIS","application_number":"NDA022266"}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}