{"id":"fentanyl-buccal-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nausea"},{"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":"Fentanyl is a potent synthetic opioid agonist that binds to mu opioid receptors throughout the brain and spinal cord, inhibiting pain signal transmission and producing analgesia. The buccal tablet formulation allows for rapid transmucosal absorption, bypassing first-pass hepatic metabolism and achieving faster onset compared to oral administration. This formulation is particularly useful for breakthrough pain management in opioid-tolerant patients.","oneSentence":"Fentanyl buccal tablet delivers the opioid fentanyl through the buccal mucosa to provide rapid analgesia by binding to mu opioid receptors in the central nervous system.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:12:11.352Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Breakthrough cancer pain in opioid-tolerant patients"}]},"trialDetails":[{"nctId":"NCT04188418","phase":"PHASE3","title":"Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2020-10-23","conditions":"Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm","enrollment":150},{"nctId":"NCT04635852","phase":"PHASE2","title":"Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Cancer Patients","status":"COMPLETED","sponsor":"University of Cologne","startDate":"2013-03","conditions":"Cancer, Dyspnea, Paroxysmal","enrollment":10},{"nctId":"NCT01856114","phase":"PHASE2","title":"Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2014-05-27","conditions":"Advanced Cancers","enrollment":36},{"nctId":"NCT03809455","phase":"PHASE2","title":"Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients","status":"WITHDRAWN","sponsor":"UNICANCER","startDate":"2020-02-01","conditions":"Breakthrough Pain","enrollment":""},{"nctId":"NCT01270659","phase":"PHASE3","title":"Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury","status":"COMPLETED","sponsor":"University of Oklahoma","startDate":"2011-05","conditions":"Pain","enrollment":60},{"nctId":"NCT01946555","phase":"","title":"Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain","status":"COMPLETED","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2013-09","conditions":"Tumor, Cancer Pain, Breakthrough Cancer Pain","enrollment":150},{"nctId":"NCT00387010","phase":"PHASE3","title":"Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain","status":"TERMINATED","sponsor":"Cephalon","startDate":"2006-12","conditions":"Pain, Chronic Pain, Breakthrough Pain","enrollment":218},{"nctId":"NCT00842829","phase":"PHASE4","title":"Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients","status":"TERMINATED","sponsor":"Cephalon","startDate":"2009-01","conditions":"Cancer Pain, Breakthrough Pain","enrollment":330},{"nctId":"NCT00463047","phase":"PHASE3","title":"Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain","status":"COMPLETED","sponsor":"Cephalon","startDate":"2007-07","conditions":"Chronic Pain","enrollment":323},{"nctId":"NCT00813488","phase":"PHASE3","title":"Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain","status":"COMPLETED","sponsor":"Cephalon","startDate":"2008-12","conditions":"Chronic Pain","enrollment":213}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":61,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Fentora","CEP-25608"],"phase":"phase_3","status":"active","brandName":"Fentanyl Buccal Tablet","genericName":"Fentanyl Buccal Tablet","companyName":"M.D. Anderson Cancer Center","companyId":"m-d-anderson-cancer-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fentanyl buccal tablet delivers the opioid fentanyl through the buccal mucosa to provide rapid analgesia by binding to mu opioid receptors in the central nervous system. Used for Breakthrough cancer pain in opioid-tolerant patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}