Axsome Therapeutics Receives FDA Approval for AUVELITY in Alzheimer’s Disease Agitation

On April 30, 2026, Axsome Therapeutics 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. This marks the second neuropsychiatric indication for AUVELITY, which is already approved for major depressive disorder. The approval was supported by data from the Phase 3 ADVANCE-1 and ACCORD-2 trials. In ADVANCE-1, AUVELITY demonstrated statistical significance over placebo in improving agitation symptoms as measured by the Cohen-Mansfield Agitation Inventory (CMAI) total score at Week 5. The ACCORD-2 randomized withdrawal trial showed that patients continuing AUVELITY experienced a significantly longer time to relapse compared to those switched to placebo. AUVELITY, which targets NMDA and sigma-1 receptors, was evaluated under FDA Priority Review and previously received Breakthrough Therapy designation for this indication. The company plans to host a webcast on May 1, 2026, to discuss the approval.