USFDAApr 30, 2026, 02:08 PM
AXSM AUVELITY FDA Approved for Alzheimer's Agitation
AI Summary
Axsome Therapeutics, Inc. 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 first-in-class treatment targets the NMDA and sigma-1 receptors and received FDA Breakthrough Therapy designation and Priority Review. The approval is supported by positive results from the Phase 3 ADVANCE-1 and ACCORD-2 studies, demonstrating significant improvement in agitation symptoms and a longer time to relapse with a favorable safety profile. Axsome will host a webcast on May 1, 2026, to discuss this significant milestone.
Key Highlights
- AUVELITY received FDA approval for agitation associated with dementia due to Alzheimer's disease.
- It is a first-in-class treatment targeting NMDA and sigma-1 receptors.
- AUVELITY was granted FDA Breakthrough Therapy designation and evaluated under Priority Review.
- Clinical program included Phase 3 ADVANCE-1 and ACCORD-2 studies.
- ADVANCE-1 showed statistically significant superiority over placebo in improving agitation symptoms.
- ACCORD-2 demonstrated a statistically significantly longer time to relapse of agitation symptoms.
- Safety profile established across trials, with 1.3% discontinuation due to adverse events, matching placebo.
- AUVELITY is also FDA-approved for major depressive disorder.
- Axsome will host a webcast on May 1, 2026, at 8:00 AM ET to discuss the approval.