NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Aug 2022
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
7/8 — Comprehensive
Priority Review
AUVELITY (dextromethorphan hydrobromide, bupropion hydrochloride) by Axsome Therapeutics is (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. Approved for major depressive disorder (mdd) in adults. First approved in 2022.
Drug data last refreshed 10h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUVELITY is an oral extended-release fixed-dose combination of dextromethorphan hydrobromide and bupropion hydrochloride approved for major depressive disorder (MDD) in adults. Dextromethorphan acts as a sigma-1 receptor agonist and ionotropic glutamate receptor modulator, while bupropion enhances noradrenergic and dopaminergic activity and increases dextromethorphan plasma levels via CYP2D6 inhibition. The combination mechanism in MDD remains incompletely understood but represents a novel approach to antidepressant therapy.
$0.034BPart D
Peak17.1 years to LOEEarly-stage specialty product at peak adoption with growing claims volume, indicating expanding commercial infrastructure and team-building opportunities.
Mechanism of Action
(an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of dextromethorphan in the treatment of MDD is unclear. The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion…
Indications (1)
Why This Matters for Your Career
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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.