{"id":"buprenorphine-transdermal-patches","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Nausea"},{"rate":"10-15","effect":"Dizziness"},{"rate":"5-10","effect":"Headache"},{"rate":"10-15","effect":"Constipation"},{"rate":"5-10","effect":"Application site reactions"},{"rate":"5-10","effect":"Somnolence"},{"rate":"5-10","effect":"Vomiting"}]},"_chembl":{"chemblId":"CHEMBL2368861","moleculeType":"Small molecule","molecularWeight":"504.11"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Buprenorphine's partial agonist activity at the mu-opioid receptor produces a ceiling effect on respiratory depression, making it safer than full opioid agonists. The transdermal patch formulation provides sustained drug delivery over several days, improving compliance and reducing fluctuations in plasma levels. This mechanism makes it suitable for both chronic pain management and opioid use disorder treatment.","oneSentence":"Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to opioid receptors in the central nervous system to provide analgesia and reduce opioid cravings.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:55:26.557Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic moderate to severe pain"},{"name":"Opioid use disorder (maintenance treatment)"}]},"trialDetails":[{"nctId":"NCT06442566","phase":"PHASE1, PHASE2","title":"ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain","status":"RECRUITING","sponsor":"Medical University of South Carolina","startDate":"2024-08-12","conditions":"Opioid Withdrawal, Chronic Pain","enrollment":240},{"nctId":"NCT05790252","phase":"PHASE3","title":"Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2023-11-27","conditions":"Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk","enrollment":40},{"nctId":"NCT06949826","phase":"PHASE4","title":"Buprenorphine as a Post-operative Analgesic in Opioid-Naive Patients After Ankle Fracture Surgery","status":"RECRUITING","sponsor":"Jenna-Leigh Wilson","startDate":"2025-04-21","conditions":"Pain, Postoperative, Ankle Fracture Surgery, Opioid Use Disorder","enrollment":100},{"nctId":"NCT06772324","phase":"NA","title":"An Exploratory Clinical Study of a Low-dose Buprenorphine Patch for the Treatment of Autism Spectrum Disorders","status":"NOT_YET_RECRUITING","sponsor":"Peking University Sixth Hospital","startDate":"2025-01","conditions":"Autism Spectrum Disorder","enrollment":60},{"nctId":"NCT06742554","phase":"PHASE4","title":"Comparative Efficacy of Buprenorphine Transdermal Patch Versus Tramadol in Postoperative Analgesia for Shoulder Arthroscopy","status":"ACTIVE_NOT_RECRUITING","sponsor":"medina medical center","startDate":"2024-12-01","conditions":"Postoperative Pain, Shoulder Pain, Opioid Analgesia","enrollment":70},{"nctId":"NCT05871424","phase":"NA","title":"Transdermal Buprenorphine Patch for Laparoscopic Cholecystectomy","status":"COMPLETED","sponsor":"Gangnam Severance Hospital","startDate":"2023-06-11","conditions":"Laparoscopic Cholecystectomy","enrollment":66},{"nctId":"NCT06124170","phase":"","title":"Improved Pain Management in Knee Osteoarthritis-related Surgeries","status":"COMPLETED","sponsor":"Peng Liu","startDate":"2016-03-01","conditions":"Knee Osteoarthritis, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty","enrollment":714},{"nctId":"NCT02138357","phase":"PHASE4","title":"Butrans for Treatment of Restless Legs Syndrome","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2014-04","conditions":"Restless Legs Syndrome","enrollment":""},{"nctId":"NCT05852093","phase":"EARLY_PHASE1","title":"Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2023-06-01","conditions":"Rotator Cuff Tears","enrollment":100},{"nctId":"NCT03977012","phase":"","title":"Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients","status":"UNKNOWN","sponsor":"Seoul National University Hospital","startDate":"2019-06-11","conditions":"Complex Regional Pain Syndromes","enrollment":20},{"nctId":"NCT05042648","phase":"PHASE4","title":"Role of Preoperative Transdermal Buprenorphine Patch in Reducing Postoperative Opioids Consumption in Patients Undergoing Total Knee Arthroplasties - A Randomised Controlled Trial.","status":"UNKNOWN","sponsor":"Security Forces Hospital","startDate":"2021-12-01","conditions":"Patients Aged Between 18 and 65years Undergoing Total Knee Arthroplasty","enrollment":120},{"nctId":"NCT03380533","phase":"PHASE2, PHASE3","title":"Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair","status":"COMPLETED","sponsor":"Hospital Italiano de Buenos Aires","startDate":"2016-09-22","conditions":"Rotator Cuff Tear, Rotator Cuff Injury, Analgesics, Opioid","enrollment":50},{"nctId":"NCT03967327","phase":"PHASE3","title":"A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain","status":"UNKNOWN","sponsor":"Mundipharma (China) Pharmaceutical Co. Ltd","startDate":"2019-04-22","conditions":"Cancer Pain","enrollment":194},{"nctId":"NCT03975010","phase":"PHASE1","title":"Buprenorphine Transdermal Patches Pharmacokinetic Study","status":"UNKNOWN","sponsor":"Mundipharma (China) Pharmaceutical Co. Ltd","startDate":"2019-05-13","conditions":"Chronic Pain","enrollment":45},{"nctId":"NCT03947125","phase":"","title":"New Application of Buprenorphine Patch on Painful Knee Joint in Knee Osteoarthritis Patients","status":"UNKNOWN","sponsor":"Ajou University School of Medicine","startDate":"2019-05-15","conditions":"Knee Osteoarthritis","enrollment":200},{"nctId":"NCT03785613","phase":"PHASE1","title":"Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2005-11-07","conditions":"Pain","enrollment":47},{"nctId":"NCT03770234","phase":"PHASE1","title":"Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours","status":"COMPLETED","sponsor":"Grünenthal GmbH","startDate":"2004-04-05","conditions":"Pain, Pharmacokinetics","enrollment":30},{"nctId":"NCT01999114","phase":"PHASE1","title":"The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2012-03","conditions":"ECG Effects","enrollment":328},{"nctId":"NCT00947466","phase":"PHASE1, PHASE2","title":"A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain","status":"TERMINATED","sponsor":"Mundipharma Research Limited","startDate":"2010-02","conditions":"Chemotherapy Induced Mucositis, Mouth Pain","enrollment":25},{"nctId":"NCT02416804","phase":"PHASE4","title":"Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2015-01","conditions":"Spinal Stenosis, Pain, Postoperative","enrollment":69},{"nctId":"NCT01961271","phase":"PHASE4","title":"Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain","status":"COMPLETED","sponsor":"Mundipharma Pte Ltd.","startDate":"2013-06","conditions":"Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain","enrollment":114},{"nctId":"NCT02519387","phase":"PHASE4","title":"Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity","status":"COMPLETED","sponsor":"Mundipharma Pharmaceuticals Sdn. Bhd.","startDate":"2013-07","conditions":"Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain","enrollment":78},{"nctId":"NCT02431624","phase":"PHASE1","title":"An Assessment of Buprenorphine Transdermal Delivery System (BTDS) Patch Adhesion","status":"COMPLETED","sponsor":"Mundipharma Research Limited","startDate":"2015-03","conditions":"Pain","enrollment":40},{"nctId":"NCT02268422","phase":"PHASE1","title":"Bioequivalence and Adhesion Comparison of Buprenorphine Patches","status":"COMPLETED","sponsor":"Mundipharma Research Limited","startDate":"2014-10","conditions":"Pain","enrollment":104},{"nctId":"NCT00387777","phase":"PHASE1","title":"Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations","status":"TERMINATED","sponsor":"Grünenthal GmbH","startDate":"2006-10","conditions":"Healthy","enrollment":24},{"nctId":"NCT01643759","phase":"PHASE1","title":"Norspan Transdermal Patches Study in Osteoarthritis Patients","status":"COMPLETED","sponsor":"Mundipharma (China) Pharmaceutical Co. Ltd","startDate":"2009-07","conditions":"Osteoarthritis Disorders","enrollment":30},{"nctId":"NCT01476774","phase":"PHASE3","title":"NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain","status":"COMPLETED","sponsor":"Mundipharma (China) Pharmaceutical Co. Ltd","startDate":"2009-08","conditions":"Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)","enrollment":280},{"nctId":"NCT01019265","phase":"PHASE4","title":"A Study Comparing Norspan Patch and Oral Tramadol","status":"COMPLETED","sponsor":"Mundipharma Korea Ltd","startDate":"2008-03","conditions":"Osteoarthritis","enrollment":170},{"nctId":"NCT02160067","phase":"PHASE1","title":"A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches","status":"COMPLETED","sponsor":"Mundipharma Research Limited","startDate":"2014-05","conditions":"Pain","enrollment":20},{"nctId":"NCT01259115","phase":"PHASE1","title":"Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2002-10","conditions":"Healthy","enrollment":20},{"nctId":"NCT01225861","phase":"","title":"Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK","status":"COMPLETED","sponsor":"Mundipharma Research Limited","startDate":"2010-11","conditions":"Chronic Pain","enrollment":750},{"nctId":"NCT01276431","phase":"PHASE4","title":"Norspan Efficacy and Safety Among Elderly Subjects","status":"COMPLETED","sponsor":"Mundipharma AB","startDate":"2011-03","conditions":"Osteoarthritis Pain of the Hip and or Knee","enrollment":102},{"nctId":"NCT01135524","phase":"PHASE3","title":"Safety of Buprenorphine Transdermal Patch (BTDS) in Osteoarthritis Pain: a 52-Week Extension Phase","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2004-04","conditions":"Osteoarthritis","enrollment":196},{"nctId":"NCT00531427","phase":"PHASE3","title":"Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2007-09","conditions":"Chronic Pain, Osteoarthritis of the Knee","enrollment":567},{"nctId":"NCT00312195","phase":"PHASE3","title":"Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2001-03","conditions":"Chronic Non-malignant Pain","enrollment":267},{"nctId":"NCT01151098","phase":"PHASE3","title":"Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2001-04","conditions":"Chronic Nonmalignant Pain","enrollment":189},{"nctId":"NCT00490919","phase":"PHASE3","title":"Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2007-06","conditions":"Low Back Pain","enrollment":539},{"nctId":"NCT00312221","phase":"PHASE3","title":"Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2004-04","conditions":"Osteoarthritis","enrollment":418},{"nctId":"NCT00403234","phase":"PHASE2","title":"Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2006-11","conditions":"Postoperative Pain","enrollment":10},{"nctId":"NCT00315458","phase":"PHASE3","title":"Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2003-12","conditions":"Osteoarthritis","enrollment":107},{"nctId":"NCT00320801","phase":"PHASE3","title":"Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2004-01","conditions":"Osteoarthritis","enrollment":188},{"nctId":"NCT01148537","phase":"PHASE1","title":"The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2004-07","conditions":"Healthy Volunteers","enrollment":132},{"nctId":"NCT01125917","phase":"PHASE3","title":"Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2004-06","conditions":"Back Pain Lower Back Chronic","enrollment":354},{"nctId":"NCT00313846","phase":"PHASE3","title":"Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2003-04","conditions":"Osteoarthritis","enrollment":529},{"nctId":"NCT01141283","phase":"PHASE3","title":"Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2003-04","conditions":"Osteoarthritis","enrollment":290},{"nctId":"NCT00313014","phase":"PHASE3","title":"Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain","status":"TERMINATED","sponsor":"Purdue Pharma LP","startDate":"2004-02","conditions":"Back Pain Lower Back Chronic","enrollment":660},{"nctId":"NCT00312572","phase":"PHASE3","title":"Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2003-06","conditions":"Osteoarthritis","enrollment":204},{"nctId":"NCT00315445","phase":"PHASE3","title":"The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"1997-12","conditions":"Back Pain","enrollment":134},{"nctId":"NCT01259102","phase":"PHASE1","title":"Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2000-11","conditions":"Healthy","enrollment":70},{"nctId":"NCT00324038","phase":"PHASE4","title":"Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly","status":"COMPLETED","sponsor":"Napp Pharmaceuticals Limited","startDate":"2006-03","conditions":"Osteoarthritis","enrollment":219},{"nctId":"NCT00426647","phase":"PHASE4","title":"Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine","status":"COMPLETED","sponsor":"Norpharma A/S","startDate":"2007-02","conditions":"Osteoarthritis, Pain","enrollment":120},{"nctId":"NCT00345787","phase":"PHASE3","title":"Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain","status":"COMPLETED","sponsor":"Mundipharma K.K.","startDate":"2006-05","conditions":"Pain, Osteoarthritis","enrollment":262},{"nctId":"NCT00346047","phase":"PHASE3","title":"Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain","status":"COMPLETED","sponsor":"Mundipharma K.K.","startDate":"2006-05","conditions":"Low Back Pain","enrollment":238},{"nctId":"NCT00469404","phase":"PHASE1","title":"Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)","status":"TERMINATED","sponsor":"Grünenthal GmbH","startDate":"2007-05","conditions":"Healthy","enrollment":24},{"nctId":"NCT00469053","phase":"PHASE1","title":"Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID: 855509)","status":"TERMINATED","sponsor":"Grünenthal GmbH","startDate":"2007-05","conditions":"Healthy","enrollment":36},{"nctId":"NCT00388219","phase":"PHASE1","title":"Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations","status":"TERMINATED","sponsor":"Grünenthal GmbH","startDate":"2006-10","conditions":"Healthy","enrollment":24}],"_emaApprovals":[],"_faersSignals":[{"count":4,"reaction":"PRODUCT ADHESION ISSUE"},{"count":3,"reaction":"PAIN"},{"count":1,"reaction":"APPLICATION SITE PAIN"},{"count":1,"reaction":"APPLICATION SITE RASH"},{"count":1,"reaction":"DRUG INEFFECTIVE"},{"count":1,"reaction":"HYPERSENSITIVITY"},{"count":1,"reaction":"PRODUCT SUBSTITUTION ISSUE"},{"count":1,"reaction":"PRURITUS"}],"_approvalHistory":[],"publicationCount":17,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Buprenorphine transdermal patches","genericName":"Buprenorphine transdermal patches","companyName":"Mundipharma (China) Pharmaceutical Co. Ltd","companyId":"mundipharma-china-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Buprenorphine is a partial mu-opioid receptor agonist that binds with high affinity to opioid receptors in the central nervous system to provide analgesia and reduce opioid cravings. Used for Chronic moderate to severe pain, Opioid use disorder (maintenance treatment).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}