Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-05 for the treatment of major depressive disorder

Axsome Therapeutics

27 March 2019 - Designation offers potential for expedited development and review.

Axsome Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for AXS-05 for the treatment of major depressive disorder (MDD). AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

The designation for AXS-05 in MDD was supported by the recent positive results from the Phase 2 ASCEND study, a randomised, double-blind, active-controlled, multi-centre, U.S. trial, in which 80 patients with confirmed moderate to severe MDD were treated with AXS-05 or the active comparator bupropion.

Read Axsome Therapeutics press release

Michael Wonder

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Michael Wonder