FDA accepts priority review for new drug application (NDA) for AXS-05 (dextromethorphan-bupropion) to treat major depressive disorder

The NDA for this novel, oral, investigational NMDA receptor antagonist with multimodal activity is supported by results from 2 RCT’s, GEMINI and ASCEND trials, which showed statistically significant improvements in depressive symptoms with AXS-05 vs placebo and active controls.

Source:

Biospace Inc.