The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug AXS-05 (Axsome Therapeutics) for patients with treatment resistant depression (TRD).

Treatment resistant depression is defined as having a diagnosis of major depressive disorder (MDD) with the failure of two or more antidepressant therapies. Currently, there are limited treatment options for TRD. 

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Axsome is currently investigating AXS-05 in a randomized, double-blind, active-controlled Phase 3 study, STRIDE-1, to evaluate its efficacy and safety in the treatment of TRD. Additionally, the Company also intends to study AXS-05 in a Phase 2/3 trial for agitation associated with Alzheimer’s disease.

AXS-05 is a novel, oral combination of bupropion and dextromethorphan. Bupropion, a norepinephrine/dopamine reuptake inhibitor and a nicotinic acetylcholine receptor antagonist, serves to increase the bioavailability of dextromethorphan, an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin/norepinephrine transporter inhibitor.

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