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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUVELITY is a fixed-dose combination tablet containing dextromethorphan hydrobromide and bupropion hydrochloride, approved by the FDA in August 2022 for treatment of major depressive disorder (MDD) in adults. Dextromethorphan acts as an ionotropic glutamate receptor and sigma-1 receptor agonist, while bupropion works through noradrenergic and dopaminergic mechanisms. Bupropion inhibits cytochrome P450 2D6, thereby increasing plasma levels of dextromethorphan. The combination represents a novel mechanism approach within the MDD treatment landscape, distinct from traditional SSRIs and SNRIs.
$0.0BPart D
17.0 years to LOEMechanism 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)
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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.