AXSM · Axsome Therapeutics, Inc.

The FDA approval of AUVELITY for agitation associated with dementia due to Alzheimer’s disease represents a major milestone for Axsome Therapeutics, addressing a critical unmet need in a condition affecting up to 76% of over 7 million U.S. Alzheimer’s patients. Agitation, characterized by emotional distress, aggression, and irritability, accelerates cognitive decline, increases caregiver burden, and drives nursing home placements. AUVELITY, a first-in-class NMDA receptor antagonist and sigma-1 agonist, demonstrated superiority over placebo in the Phase 3 ADVANCE-1 trial on the primary endpoint of CMAI total score improvement at Week 5 and key secondary mADCS-CGIC response. The ACCORD-2 long-term withdrawal study showed significantly longer time to relapse versus placebo. Tolerability was strong, with common adverse events like dizziness and dyspepsia, and 1.3% discontinuation rate equivalent to placebo. CEO Herriot Tabuteau highlighted its distinct mechanism and pioneering role in neuroscience. Experts like Jeffrey Cummings and George Grossberg emphasized its potential to transform care for this burdensome symptom. With prior approval for MDD in 2022, robust patent protection to 2043, and over 300,000 patients treated, this expands AUVELITY’s market while introducing comprehensive patient support via Auvelity OnMySide, including savings for insured patients and samples, available at launch.