April 30, 2026
We are pleased to share that Axsome Therapeutics’ Auvelity has been granted FDA approval for the treatment of agitation associated with Alzheimer’s dementia. As the first non-antipsychotic option for this condition, Auvelity targets the NMDA and sigma-1 receptors to help manage symptoms like aggression and restlessness without the cognitive decline or sedation often associated with older treatments. This follows a Priority Review and Breakthrough Therapy designation, underscoring the urgent need for safer, more effective treatments.
Agitation affects up to 76% of Alzheimer’s patients and is one of the leading causes of caregiver burnout and early institutionalization. Clinical trials, including the ADVANCE-1 and ACCORD studies, demonstrated that Auvelity significantly reduced agitation scores and delayed the time to relapse compared to a placebo. This approval provides clinicians with a first-in-class tool to improve the quality of life for both patients and their families.
More information is available here: https://practicalneurology.com/news/first-non-antipsychotic-treatment-for-agitation-associated-with-alzheimer-disease-dementia-approved-by-fda/2486920/#:~:text=%E2%80%9CThe%20approval%20of%20Auvelity%20is,Louis%20University%20School%20of%20Medicine.