{"id":"nuedexta-20-10","safety":{"commonSideEffects":[{"rate":"13","effect":"Dizziness"},{"rate":"9","effect":"Headache"},{"rate":"8","effect":"Nausea"},{"rate":"7","effect":"Asthenia/fatigue"},{"rate":"5","effect":"Vomiting"},{"rate":"2","effect":"Syncope"}]},"_chembl":{"chemblId":"CHEMBL3955874","moleculeType":"Small molecule","molecularWeight":"652.74"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dextromethorphan acts as a sigma-1 receptor agonist, which modulates glutamatergic and monoaminergic neurotransmission involved in emotional regulation. Quinidine is added as a CYP2D6 inhibitor to increase dextromethorphan bioavailability and maintain therapeutic levels. Together, these components suppress the involuntary laughing or crying episodes characteristic of pseudobulbar affect.","oneSentence":"Nuedexta combines dextromethorphan (a sigma-1 receptor agonist) and quinidine (a CYP2D6 inhibitor) to reduce involuntary emotional expression disorder (pseudobulbar affect) by modulating emotional pathways in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:41:47.917Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Pseudobulbar affect (involuntary emotional expression disorder)"}]},"trialDetails":[{"nctId":"NCT01584440","phase":"PHASE2","title":"Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","startDate":"2012-08-13","conditions":"Agitation, Alzheimer's Disease","enrollment":220},{"nctId":"NCT01324232","phase":"PHASE2","title":"Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","startDate":"2011-09-08","conditions":"Central Neuropathic Pain, Multiple Sclerosis","enrollment":209},{"nctId":"NCT01832350","phase":"PHASE4","title":"Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease","status":"TERMINATED","sponsor":"St. Joseph's Hospital and Medical Center, Phoenix","startDate":"2012-08-28","conditions":"Alzheimer's Disease, Pseudobulbar Affect (PBA)","enrollment":34},{"nctId":"NCT02176018","phase":"PHASE2","title":"Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine","status":"COMPLETED","sponsor":"Cady, Roger, M.D.","startDate":"2014-08","conditions":"Episodic Migraine","enrollment":76},{"nctId":"NCT03381664","phase":"PHASE1","title":"Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","startDate":"2017-11-28","conditions":"Healthy Adult Male and Female Volunteers","enrollment":17},{"nctId":"NCT01630811","phase":"PHASE2","title":"Nuedexta for the Treatment of Adults With Autism","status":"COMPLETED","sponsor":"Sutter Health","startDate":"2012-01-24","conditions":"Autism","enrollment":13},{"nctId":"NCT02496039","phase":"PHASE4","title":"Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)","status":"TERMINATED","sponsor":"Avanir Pharmaceuticals","startDate":"2015-09","conditions":"Pseudobulbar Affect (Involuntary Laughing and/or Crying)","enrollment":5},{"nctId":"NCT00573443","phase":"PHASE3","title":"Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","startDate":"2007-12","conditions":"Pseudobulbar Affect (PBA)","enrollment":326},{"nctId":"NCT01799941","phase":"PHASE4","title":"Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)","status":"COMPLETED","sponsor":"Avanir Pharmaceuticals","startDate":"2013-02","conditions":"Pseudobulbar Affect (PBA), Stroke, Dementia","enrollment":367}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Dextromethorphan/Quinidine"],"phase":"marketed","status":"active","brandName":"Nuedexta (20/10)","genericName":"Nuedexta (20/10)","companyName":"St. Joseph's Hospital and Medical Center, Phoenix","companyId":"st-joseph-s-hospital-and-medical-center-phoenix","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Nuedexta combines dextromethorphan (a sigma-1 receptor agonist) and quinidine (a CYP2D6 inhibitor) to reduce involuntary emotional expression disorder (pseudobulbar affect) by modulating emotional regulation pathways in the brain. Used for Pseudobulbar affect (involuntary emotional expression disorder).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}