Dextromethorphan/Quinidine: A Review of Its Use in Adults with Pseudobulbar Affect
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Fixed-dose dextromethorphan/quinidine capsules (Nuedexta®) utilize quinidine to inhibit the metabolism of dextromethorphan, enabling high plasma dextromethorphan concentrations to be reached without using a larger dose of the drug. The drug combination is the first treatment to be approved for pseudobulbar affect (PBA), a condition of contextually inappropriate/exaggerated emotional expression that often occurs in adults with neurological damage conditions, such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, traumatic brain injury, Alzheimer’s disease or Parkinson’s disease. Dextromethorphan/quinidine at the recommended dosages of 20/10 or 30/10 mg twice daily reduced the rate of PBA episodes and improved PBA severity in a 12-week, double-blind, placebo-controlled trial in adults with ALS or MS (STAR), with further improvements in the severity of the condition observed in a 12-week open-label extension phase. Dextromethorphan/quinidine 20/10 mg twice daily also improved PBA secondary to dementia in a cohort of a 12-week noncomparative trial (PRISM II). The drug combination was generally well tolerated in these studies, with no particular safety or tolerability concerns. Although longer-term efficacy and tolerability data for dextromethorphan/quinidine 20/10 or 30/10 mg twice daily would be beneficial, current evidence indicates that it is a useful option in the treatment of adults with PBA.
KeywordsMultiple Sclerosis Amyotrophic Lateral Sclerosis Quinidine Amyotrophic Lateral Sclerosis Patient Dextromethorphan
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit. Lily Yang and Emma Deeks are salaried employees of Springer.
- 7.European Medicines Agency. Nuedexta (dextromethorphan/quinidine) oral capsules: EU summary of product characteristics. http://www.ema.europa.eu. Accessed 5 Nov 2014.
- 8.Avanir Pharmaceuticals Inc. Nuedexta® (dextromethorphan hydrobromide and quinidine sulfate) oral capsules: US prescribing information. 2010. https://www.nuedexta.com. Accessed 5 Nov 2014.
- 10.Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: multidisciplinary care, symptom management, and cognitive/behavioral impairment (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009;73(15):1227–33.PubMedCentralPubMedCrossRefGoogle Scholar
- 14.Brooks BR, Bravver E, Desai UG, et al. Bulbar speech-articulation/swallowing rate changes measured in amyotrophic lateral sclerosis (ALS) patients treated with dextromethorphan/quinidine(nuedexta) for pseudobulbar affect (PBA)-determination of treatment effect size for future clinical trials [abstract no. M1408]. Ann Neurol. 2012;72(S16):S65–6.Google Scholar
- 16.European Medicines Agency. Neudexta (dextromethorphan/quinidine): assessment report for an initial marketing authorisation application. 25 Apr 2013. http://www.ema.europa.eu. Accessed 5 Nov 2014.
- 21.Pioro E, Brooks B, Cummings J, et al. Persistent efficacy of dextromethorphan (DM)/quinidine (Q) for pseudobulbar affect (PBA): results from a 12-week, open-label extension (OLE) study [abstract no. LBS.006]. Neurology. 2010;75(4):380.Google Scholar
- 22.Doody RS, D’Amico S, Cutler AJ, et al. Safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with Alzheimer’s disease/dementia: PRISM II [poster no. M1334WIP]. In: 139th Annual Meeting of the American Neurological Association, Baltimore (MD); 2014.Google Scholar
- 23.Avanir Pharmaceuticals. Safety and efficacy of AVP-923 in PBA patients with ALS or MS (STAR) [ClinicalTrial.gov identifier NCT00573443]. US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov. Accessed 5 Nov 2014.
- 24.Jillapalli D. US FDA center for drug evaluation and research: medical review of Zenvia. 25 Sep 2010. http://www.accessdata.fda.gov. Accessed 30 Aug 2013.
- 25.Pioro E, Brooks B, Cummings J, et al. Safety and tolerability of dextromethorphan/quinidine for pseudobulbar affect in a 12-week, open-label extension study [abstract no. P06.128]. In: 62nd Annual Meeting of the American Academy of Neurology, Toronto (ON); 2010.Google Scholar
- 26.Siffert J, Abijo O, Formella A. Dextromethorphan 20 mg/quinidine 10 mg effectiveness and tolerability in treating PBA in patients with stroke, dementia and other neurological conditions: results of a retrospective chart review [abstract]. Consult Pharm. 2013;28(10).Google Scholar
- 27.Cruz MP. Nuedexta for the treatment of pseudobulbar affect. Drug Forcast. 2013;38(6):325–8.Google Scholar
- 29.Cummings JL. Neuropsychiatric inventory: comprehensive assessment of psychopathology in patients with dementia. 2009. http://www.dementia-assessment.com.au/behavioural/index.html. Accessed 5 Nov 2014.