AUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to Alzheimer's disease 

The safety and tolerability profile of AUVELITY in agitation associated with dementia due to Alzheimer's disease has been established across short-term and long-term trials

AUVELITY was developed with FDA Breakthrough Therapy designation and evaluated by the FDA under Priority Review

Company to host webcast Friday, May 1, at 8:00 AM Eastern Time

NEW YORK, April 30, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITY® (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer's disease.1 AUVELITY is a first-in-class treatment for Alzheimer's disease agitation which targets the N-methyl D-aspartate (NMDA) and sigma-1 receptors.