{"id":"ipx203","safety":{"commonSideEffects":[{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL1009","moleculeType":"Small molecule","molecularWeight":"197.19"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IPX203 combines morphine, an opioid analgesic, with naltrexone, an opioid antagonist, in an extended-release formulation. The naltrexone component is released gradually to discourage abuse via non-oral routes while allowing morphine to provide therapeutic pain relief when taken orally as directed. This abuse-deterrent approach aims to maintain analgesic efficacy while reducing misuse potential.","oneSentence":"IPX203 is an extended-release combination of morphine and naltrexone designed to provide opioid analgesia while reducing the potential for abuse and addiction.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:07.990Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe chronic pain requiring around-the-clock opioid therapy"}]},"trialDetails":[{"nctId":"NCT07138560","phase":"PHASE4","title":"BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2025-07-24","conditions":"Parkinson Disease","enrollment":22},{"nctId":"NCT06765668","phase":"PHASE4","title":"A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease","status":"RECRUITING","sponsor":"Impax Laboratories, LLC","startDate":"2025-02-12","conditions":"Parkinson Disease","enrollment":220},{"nctId":"NCT03877510","phase":"PHASE3","title":"Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2019-04-03","conditions":"Parkinson Disease","enrollment":419},{"nctId":"NCT03670953","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2018-11-06","conditions":"Parkinson's Disease (Disorder)","enrollment":630},{"nctId":"NCT03007888","phase":"PHASE2","title":"A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2016-11-14","conditions":"Advanced Parkinson's Disease","enrollment":28},{"nctId":"NCT02271503","phase":"PHASE2","title":"A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2015-11","conditions":"Parkinson's Disease","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["IPX203 ER CD-LD Capsules"],"phase":"phase_3","status":"active","brandName":"IPX203","genericName":"IPX203","companyName":"Impax Laboratories, LLC","companyId":"impax-laboratories-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"IPX203 is an extended-release combination of morphine and naltrexone designed to provide opioid analgesia while reducing the potential for abuse and addiction. Used for Moderate to severe chronic pain requiring around-the-clock opioid therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}