AUVELITY
AUVELITY (dextromethorphan-bupropion) is a once-daily oral combination tablet developed by Axsome Therapeutics for major depressive disorder (MDD) that targets brain pathways distinct from traditional antidepressants. Dextromethorphan acts as an NMDA glutamate receptor antagonist and sigma-1 receptor agonist, modulating glutamate transmission believed to contribute to depression; bupropion inhibits the CYP2D6 enzyme that would otherwise rapidly break down dextromethorphan, extending its brain exposure while providing its own antidepressant activity. AUVELITY is approved for adults with MDD; Axsome is pursuing a supplemental NDA for adolescents.
Upcoming catalysts
Programs
Major Depressive Disorder
MDD affects roughly 16 million US adults annually; approximately one-third fail first-line SSRI or SNRI therapy. AUVELITY is approved for adult MDD based on the Phase 3 GEMINI trial; this program pursues a supplemental NDA to extend the indication to adolescents — a significant commercial and public health expansion — with the NDA filing in 2026 representing the key regulatory procedural milestone.