NDAORALCAPSULEPriority Review
Approved
Oct 2010
Lifecycle
Post-LOE
Competitive Pressure
35/100
Data completeness
5/8 — Partial
Priority Review
NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) by R-Pharm US is (dm) is a sigma-1 receptor agonist and an uncompetitive nmda receptor antagonist. Approved for pseudobulbar affect (pba). First approved in 2010.
Drug data last refreshed 20h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUEDEXTA is an oral capsule combining dextromethorphan (a sigma-1 receptor agonist and NMDA antagonist) with quinidine (a CYP2D6 inhibitor that elevates DM plasma levels) for treatment of pseudobulbar affect (PBA). PBA is a neurological condition characterized by involuntary emotional outbursts. The mechanism by which dextromethorphan produces therapeutic benefit in PBA remains incompletely understood.
$0.181BPart D
Post-LOEPost-LOEProduct is in post-LOE phase with declining exclusivity; commercial team is likely focused on maintaining market share against generics rather than expansion.
Mechanism of Action
(DM) is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. Quinidine increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan. The mechanism by which dextromethorphan…
Indications (1)
Why This Matters for Your Career
Worked on NUEDEXTA at R-Pharm US? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.