Investigational Agent for Major Depressive Disorder Gets FDA’s Breakthrough Designation

The designation is given to potentially expedite development and review timelines for promising therapies.

Axsome Therapeutics announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AXS-05 for the treatment of major depressive disorder (MDD).

AXS-05 consists of dextromethorphan, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, and bupropion, a norepinephrine and dopamine reuptake inhibitor that serves to increase the bioavailability of dextromethorphan.

AXS-05 was evaluated in the phase 2 multicenter, randomized, double-blind, active-controlled ASCEND trial (N=80). Study patients were treated with either AXS-05 or bupropion, the active comparator. Results showed that treatment with AXS-05 led to substantial, rapid, and statistically significant reduction in depressive symptoms vs bupropion.

A statistically significant average mean reduction from baseline in the Montgomery-Åsberg Depression Rating Scale total score (primary endpoint) was observed with AXS-05 over the 6-week treatment period compared with bupropion (13.7 points vs 8.8 points; P<.001). Nausea, dizziness, dry mouth, decreased appetite, and anxiety were the most commonly reported adverse events associated with AXS-05 in the study.

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“There is a significant unmet medical need for new and mechanistically differentiated treatments for depression. We look forward to working closely with the FDA over the coming months to expedite the development of AXS-05 for the treatment of major depressive disorder,” stated Herriot Tabuteau, MD, Chief Executive Officer of Axsome.

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