NDAORALCAPSULEPriority Review
Approved
Oct 2010
Lifecycle
LOE Approaching
Competitive Pressure
25/100
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 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUEDEXTA is an oral capsule combination of dextromethorphan hydrobromide and quinidine sulfate approved in October 2010 for the treatment of pseudobulbar affect (PBA). Dextromethorphan acts as a sigma-1 receptor agonist and uncompetitive NMDA receptor antagonist, while quinidine inhibits CYP2D6 metabolism to elevate dextromethorphan plasma levels. The mechanism by which dextromethorphan produces therapeutic benefit in PBA patients remains incompletely understood. NUEDEXTA represents a niche therapeutic option for a rare neurological condition with limited alternative treatments.
$0.2BPart D
3mo to LOEMechanism 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.