{"id":"extended-release-oxycodone","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Constipation"},{"rate":"20-30","effect":"Nausea"},{"rate":"15-25","effect":"Dizziness"},{"rate":"20-30","effect":"Drowsiness"},{"rate":"10-15","effect":"Vomiting"},{"rate":"5-10","effect":"Headache"},{"rate":null,"effect":"Respiratory depression"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Oxycodone is a semi-synthetic opioid agonist that binds primarily to mu (μ) opioid receptors in the brain and spinal cord, inhibiting pain signal transmission and modulating pain perception. The extended-release formulation provides sustained drug delivery over 12 hours, allowing for less frequent dosing compared to immediate-release formulations. This mechanism makes it suitable for chronic moderate to severe pain management.","oneSentence":"Extended-release oxycodone binds to opioid receptors in the central nervous system to reduce pain perception.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:46:09.738Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe chronic pain requiring continuous opioid therapy"},{"name":"Cancer pain"}]},"trialDetails":[{"nctId":"NCT04044820","phase":"NA","title":"Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery","status":"RECRUITING","sponsor":"University Health Network, Toronto","startDate":"2019-03-04","conditions":"Opioid Use","enrollment":292},{"nctId":"NCT04094701","phase":"NA","title":"Hip Arthroscopy Postoperative Opioid Demands","status":"RECRUITING","sponsor":"Rush University Medical Center","startDate":"2020-10-21","conditions":"Opioid Use, Pain, Femoral Acetabular Impingement","enrollment":170},{"nctId":"NCT02454712","phase":"PHASE1","title":"Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)","status":"COMPLETED","sponsor":"Ensysce Biosciences","startDate":"2016-11-16","conditions":"Healthy","enrollment":64},{"nctId":"NCT05090280","phase":"PHASE1","title":"Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)","status":"COMPLETED","sponsor":"Ensysce Biosciences","startDate":"2021-12-01","conditions":"Pharmacokinetics","enrollment":111},{"nctId":"NCT05043766","phase":"PHASE1","title":"Evaluation of Oral PF614 Relative to OxyContin (PF614-102)","status":"COMPLETED","sponsor":"Ensysce Biosciences","startDate":"2021-09-08","conditions":"Healthy Volunteers","enrollment":84},{"nctId":"NCT04522206","phase":"PHASE4","title":"An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2020-08-20","conditions":"Pain, Postoperative, Spine Injuries and Disorders, Narcotic Use","enrollment":44},{"nctId":"NCT01335542","phase":"PHASE4","title":"Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade","status":"COMPLETED","sponsor":"Hospital for Special Surgery, New York","startDate":"2010-03","conditions":"Readiness to Discharge","enrollment":91},{"nctId":"NCT03574792","phase":"NA","title":"Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy","status":"COMPLETED","sponsor":"Roswell Park Cancer Institute","startDate":"2018-05-03","conditions":"Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","enrollment":62},{"nctId":"NCT04033094","phase":"","title":"Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2017-10-16","conditions":"Baseline Epidemiologic Assessment","enrollment":17566},{"nctId":"NCT02659501","phase":"NA","title":"Liposomal Bupivacaine in Implant Based Breast Reconstruction","status":"TERMINATED","sponsor":"Loma Linda University","startDate":"2015-07","conditions":"Breast Cancer, Postoperative Pain","enrollment":24},{"nctId":"NCT01366014","phase":"PHASE2","title":"A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-06","conditions":"Osteoarthritis of the Knee","enrollment":157},{"nctId":"NCT01451385","phase":"PHASE3","title":"Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain","status":"COMPLETED","sponsor":"Mallinckrodt","startDate":"2011-09-20","conditions":"Osteoarthritis, Low Back Pain","enrollment":376},{"nctId":"NCT04448457","phase":"NA","title":"Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Tivoli","startDate":"2017-09-01","conditions":"Postoperative Pain","enrollment":72},{"nctId":"NCT04132011","phase":"PHASE4","title":"Dosing Intervals of Opioid Medication for Chronic Pain","status":"WITHDRAWN","sponsor":"University Health Network, Toronto","startDate":"2019-05-01","conditions":"Chronic Pain","enrollment":""},{"nctId":"NCT02508935","phase":"PHASE4","title":"Pharmacokinetics (PK) and Safety Study of XARTEMIS® XR in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain","status":"TERMINATED","sponsor":"Mallinckrodt","startDate":"2015-11-20","conditions":"Acute Pain","enrollment":23},{"nctId":"NCT02987920","phase":"PHASE4","title":"Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty","status":"TERMINATED","sponsor":"University of Southern California","startDate":"2017-01","conditions":"Pain, Postoperative","enrollment":23},{"nctId":"NCT03314792","phase":"PHASE4","title":"Effects of Tapentadol Versus Oxycodone After Hysterectomy.","status":"COMPLETED","sponsor":"Oslo University Hospital","startDate":"2017-12-04","conditions":"Pain, Postoperative, Pain Uterus, Pain, Acute","enrollment":86},{"nctId":"NCT01746901","phase":"PHASE1","title":"A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-02","conditions":"Healthy","enrollment":81},{"nctId":"NCT01456507","phase":"PHASE1","title":"Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-10","conditions":"Healthy","enrollment":24},{"nctId":"NCT02680847","phase":"PHASE4","title":"Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain","status":"TERMINATED","sponsor":"Pfizer","startDate":"2016-01-21","conditions":"Moderate-severe Pain","enrollment":32},{"nctId":"NCT03475862","phase":"PHASE1","title":"Nasal Human Abuse Potential of PTI-821","status":"COMPLETED","sponsor":"Pain Therapeutics","startDate":"2017-05-15","conditions":"Opioid Abuse Nondependent","enrollment":38},{"nctId":"NCT02716857","phase":"PHASE3","title":"Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain","status":"COMPLETED","sponsor":"Egalet Ltd","startDate":"2016-03","conditions":"Moderate-to-severe Chronic Low Back Pain","enrollment":549},{"nctId":"NCT02603705","phase":"PHASE3","title":"Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain","status":"COMPLETED","sponsor":"Egalet Ltd","startDate":"2016-03-07","conditions":"Moderate-to-severe Chronic Noncancer Pain","enrollment":281},{"nctId":"NCT01631513","phase":"PHASE4","title":"An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)","status":"WITHDRAWN","sponsor":"Janssen Scientific Affairs, LLC","startDate":"2012-08","conditions":"Pain, Chronic Back Pain, Chronic Low Back Pain","enrollment":""},{"nctId":"NCT00955110","phase":"PHASE4","title":"Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)","status":"COMPLETED","sponsor":"Endo Pharmaceuticals","startDate":"2009-06","conditions":"Healthy","enrollment":78},{"nctId":"NCT01165281","phase":"PHASE3","title":"A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2010-08","conditions":"Pain","enrollment":343},{"nctId":"NCT01775189","phase":"PHASE1","title":"A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-02","conditions":"Healthy","enrollment":45},{"nctId":"NCT01502644","phase":"PHASE4","title":"Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2009-02","conditions":"Chronic Low Back Pain, Degenerative Disc Disease, Depression","enrollment":81},{"nctId":"NCT01571362","phase":"PHASE3","title":"A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-06","conditions":"Chronic Pain, Low Back Pain, Analgesia","enrollment":410},{"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":"NCT01428583","phase":"PHASE3","title":"Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain","status":"COMPLETED","sponsor":"Pfizer","startDate":"2010-12","conditions":"Chronic Noncancer Pain","enrollment":395},{"nctId":"NCT00801788","phase":"PHASE1","title":"Single Dose Pharmacokinetics of Egalet® Oxycodone","status":"COMPLETED","sponsor":"Egalet Ltd","startDate":"2008-09","conditions":"Pain","enrollment":16},{"nctId":"NCT01986283","phase":"PHASE1","title":"Abuse Potential Study of PF-00345439","status":"COMPLETED","sponsor":"Pain Therapeutics","startDate":"2013-11","conditions":"Opioid Users","enrollment":67},{"nctId":"NCT02381132","phase":"PHASE3","title":"A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain","status":"TERMINATED","sponsor":"Neil Singla","startDate":"2014-11","conditions":"Post Operative Pain","enrollment":99},{"nctId":"NCT00580294","phase":"NA","title":"A Pilot Study of Switching From One Pain Medication to Another (Opioid Rotation)","status":"COMPLETED","sponsor":"Icahn School of Medicine at Mount Sinai","startDate":"2007-11","conditions":"Pain","enrollment":12},{"nctId":"NCT02391844","phase":"PHASE4","title":"Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery","status":"COMPLETED","sponsor":"International Clinical Research Institute","startDate":"2014-05","conditions":"Disorder of Knee","enrollment":50},{"nctId":"NCT01369615","phase":"PHASE3","title":"Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001","status":"COMPLETED","sponsor":"Purdue Pharma LP","startDate":"2011-10","conditions":"Pain","enrollment":23},{"nctId":"NCT01162304","phase":"PHASE4","title":"Open-Label Trial Comparing Oxycodone Medications","status":"TERMINATED","sponsor":"University of Rochester","startDate":"2010-03","conditions":"Chronic Pain","enrollment":18},{"nctId":"NCT00414453","phase":"PHASE4","title":"Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis","status":"TERMINATED","sponsor":"University of Rochester","startDate":"2007-01","conditions":"Neuropathic Pain, Chronic Pain, Multiple Sclerosis","enrollment":19},{"nctId":"NCT02238340","phase":"PHASE4","title":"Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery","status":"COMPLETED","sponsor":"Hospital Central Dr. Luis Ortega","startDate":"2012-03","conditions":"Surgery","enrollment":40},{"nctId":"NCT00361504","phase":"PHASE3","title":"A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-11","conditions":"Osteoarthritis, Hip, Osteoarthritis, Knee, Lower Back Pain","enrollment":1123},{"nctId":"NCT00364533","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety","status":"TERMINATED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-10","conditions":"Arthroplasty","enrollment":367},{"nctId":"NCT01063868","phase":"PHASE3","title":"A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)","status":"TERMINATED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2010-01","conditions":"Diabetic Neuropathy, Painful, Diabetic Polyneuropathy","enrollment":47},{"nctId":"NCT00916890","phase":"PHASE4","title":"Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain","status":"SUSPENDED","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2009-02","conditions":"Chronic Pain","enrollment":320},{"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":"NCT00449176","phase":"PHASE3","title":"A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-02","conditions":"Low Back Pain","enrollment":981},{"nctId":"NCT00421928","phase":"PHASE3","title":"Tapentadol (CG5503)","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-01","conditions":"Osteoarthritis, Knee, Pain","enrollment":1030},{"nctId":"NCT00745069","phase":"PHASE2","title":"Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-07","conditions":"Osteoarthitis, Chronic Pain, Knee Pain","enrollment":670}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ANOREXIA"},{"count":1,"reaction":"CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR"},{"count":1,"reaction":"CONSTIPATION"},{"count":1,"reaction":"DEHYDRATION"},{"count":1,"reaction":"DRUG DISPENSING ERROR"},{"count":1,"reaction":"DRUG PRESCRIBING ERROR"},{"count":1,"reaction":"HEADACHE"},{"count":1,"reaction":"ILEUS"},{"count":1,"reaction":"INCORRECT DOSAGE ADMINISTERED"},{"count":1,"reaction":"LOSS OF CONSCIOUSNESS"}],"_approvalHistory":[],"publicationCount":96,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Extended- release Oxycodone","genericName":"Extended- release Oxycodone","companyName":"Hospital Central Dr. Luis Ortega","companyId":"hospital-central-dr-luis-ortega","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Extended-release oxycodone binds to opioid receptors in the central nervous system to reduce pain perception. Used for Moderate to severe chronic pain requiring continuous opioid therapy, Cancer pain.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}