{"id":"baclofen-er","safety":{"commonSideEffects":[{"rate":"15-30","effect":"Drowsiness/sedation"},{"rate":"10-25","effect":"Dizziness"},{"rate":"10-20","effect":"Weakness/fatigue"},{"rate":"5-15","effect":"Headache"},{"rate":"5-10","effect":"Nausea"},{"rate":"5-10","effect":"Confusion"},{"rate":"5-10","effect":"Insomnia"}]},"_chembl":{"chemblId":"CHEMBL701","moleculeType":"Small molecule","molecularWeight":"213.66"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Baclofen acts as a selective agonist at GABA-B receptors, which are inhibitory G-protein coupled receptors found throughout the central nervous system. By activating these receptors, it increases chloride channel conductance and hyperpolarizes neurons, leading to decreased excitatory neurotransmitter release and reduced muscle spasticity. The extended-release formulation provides sustained therapeutic levels with less frequent dosing compared to immediate-release formulations.","oneSentence":"Baclofen ER is a GABA-B receptor agonist that reduces neuronal excitability and muscle tone by enhancing inhibitory neurotransmission in the central nervous system.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:28:07.316Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Spasticity associated with multiple sclerosis"},{"name":"Spasticity resulting from spinal cord injury or disease"},{"name":"Muscle spasticity of other origins"}]},"trialDetails":[{"nctId":"NCT01743651","phase":"PHASE3","title":"Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis","status":"COMPLETED","sponsor":"RVL Pharmaceuticals, Inc.","startDate":"2012-11","conditions":"Spasticity, Multiple Sclerosis","enrollment":353},{"nctId":"NCT00914290","phase":"PHASE2","title":"A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2009-04","conditions":"Spasticity, Multiple Sclerosis","enrollment":23},{"nctId":"NCT00488839","phase":"PHASE3","title":"IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis","status":"COMPLETED","sponsor":"Impax Laboratories, LLC","startDate":"2007-06","conditions":"Multiple Sclerosis","enrollment":173},{"nctId":"NCT02003664","phase":"PHASE2","title":"A Study of Baclofen ER","status":"WITHDRAWN","sponsor":"University of Pennsylvania","startDate":"2013-11","conditions":"Cocaine Dependence","enrollment":""},{"nctId":"NCT00802035","phase":"PHASE1","title":"ALK29-002: A Study of Baclofen Formulations in Healthy Adults","status":"COMPLETED","sponsor":"Alkermes, Inc.","startDate":"2008-11","conditions":"Alcohol Dependence","enrollment":16}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["placebo drug"],"phase":"marketed","status":"active","brandName":"Baclofen ER","genericName":"Baclofen ER","companyName":"Alkermes, Inc.","companyId":"alkermes-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Baclofen ER is a GABA-B receptor agonist that reduces neuronal excitability and muscle tone by enhancing inhibitory neurotransmission in the central nervous system. Used for Spasticity associated with multiple sclerosis, Spasticity resulting from spinal cord injury or disease, Muscle spasticity of other origins.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}