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 17h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUVELITY is a fixed-dose combination of dextromethorphan hydrobromide and bupropion hydrochloride approved for major depressive disorder in adults. Dextromethorphan acts as an ionotropic glutamate receptor and sigma-1 receptor agonist, while bupropion enhances noradrenergic and dopaminergic activity and inhibits cytochrome P450 2D6, thereby elevating dextromethorphan plasma levels. This combination targets MDD through dual mechanisms believed to enhance antidepressant efficacy.
$0.034BPart D
Peak16.7 years to LOEAUVELITY is in peak commercial phase with modest Part D adoption (33K claims, $34M spending in 2023), indicating growth trajectory potential for Commercial and Medical Affairs teams.
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
Worked on AUVELITY at Axsome Therapeutics? 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.