Axsome Therapeutics Presents Data from GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder at the 2020 American Society for Clinical Psychopharmacology Annual Meeting

Nachrichtenquelle: globenewswire
29.05.2020, 13:00  |  130   |   |   

NEW YORK, May 29, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that data from the GEMINI Phase 3 trial of AXS-05 in major depressive disorder (MDD) will be presented in oral and poster sessions at the 2020 Annual Meeting of the American Society for Clinical Psychopharmacology (ASCP), to be held virtually, May 29-30. AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

Below are the details of the presentations:

Oral Presentation
Title: Efficacy and Safety of AXS-05, an Oral NMDA Receptor Antagonist with Multimodal Activity, in Major Depressive Disorder: Results from the GEMINI Phase 3, Double-Blind, Placebo-Controlled Trial
Date: Saturday, May 30, 2020
Time: 3:55 PM – 4:05 PM Eastern Time

Poster Presentation
Title: Efficacy and Safety of AXS-05, an Oral NMDA Receptor Antagonist with Multimodal Activity, in Major Depressive Disorder: Results from the GEMINI Phase 3, Double-Blind, Placebo-Controlled Trial
Date: Saturday, May 30, 2020
Time: 12:45 PM – 2:15 PM Eastern Time

A copy of the presentations will be available shortly after the meeting on Axsome’s website at www.axsome.com.

About AXS-05

AXS-05 is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease agitation, major depressive disorder, and other central nervous system (CNS) disorders. AXS-05 consists of a proprietary formulation and dose of dextromethorphan and bupropion and utilizes Axsome’s metabolic inhibition technology. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, a sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, a nicotinic acetylcholine receptor antagonist, and an inhibitor of microglial activation. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 42 issued U.S. and international patents which provide protection out to 2034. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for the treatment of MDD, as well as Fast Track designations for the treatment of Alzheimer’s disease agitation and treatment resistant depression. AXS-05 is not approved by the FDA.

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