{"id":"bema","safety":{"commonSideEffects":[{"rate":null,"effect":"Oral irritation or mucosal irritation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BEMA (BioErodible MucoAdhesive) is a proprietary drug delivery technology platform consisting of a thin, flexible film that adheres to the buccal mucosa (inside of the cheek) and rapidly dissolves to deliver medication. This route bypasses first-pass hepatic metabolism and provides faster onset compared to oral tablets, while avoiding injection. The technology has been applied to various active ingredients including opioids and other therapeutics.","oneSentence":"BEMA is a buccal film delivery system that rapidly dissolves in the mouth to deliver active pharmaceutical ingredients through the oral mucosa for faster systemic absorption.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:01.196Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid-induced breakthrough pain (primary development indication)"},{"name":"Acute pain management"}]},"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":55,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Onsolis (fentanyl buccal soluble film)"],"phase":"phase_3","status":"active","brandName":"BEMA™","genericName":"BEMA™","companyName":"BioDelivery Sciences International","companyId":"biodelivery-sciences-international","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BEMA is a buccal film delivery system that rapidly dissolves in the mouth to deliver active pharmaceutical ingredients through the oral mucosa for faster systemic absorption. Used for Opioid-induced breakthrough pain (primary development indication), Acute pain management.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}