Nuedexta dextromethorphan/quinidine APPROVED
Drug Profile
ModalitySmall molecule
RouteORAL
Therapy AreaNeurology
Launch2010-10-29
Peak Sales Est$200M
Formulations[{"id":"nuedexta-oral","route":"ORAL","device":"Capsule (20mg/10mg DM/Q)","setting":"PATIENT_SELF","
Companies
4578 (ORIGINATOR)100%
Mechanism: NMDA Antagonist / Sigma-1 Agonist
Expert: Dextromethorphan acts as uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, modulating glutamatergic neurotransmission. Quinidine inhibits CYP2D6, increasing dextromethorphan bioavailability ~20-fold to achieve therapeutic CNS exposure.
Everyday: Calms down overexcited brain circuits that cause involuntary laughing or crying by blocking a glutamate receptor (NMDA) and activating a stabilizing receptor (sigma-1). Combined with a metabolism-slowing partner drug to keep levels high enough in the brain.
Targets: []
Programs (1)
IndicationStageKey StudyRegional Status
PBAAPPROVEDSTAR trial[{"stage":"APPROVED","region":"US","approval_date":"2010-10-29"}]
Notes
First and only FDA-approved treatment for PBA.
Data from Supabase · Updated 2026-03-24