Axsome Therapeutics received FDA acceptance and priority review designation for its supplemental new drug application for AXS-05, a treatment for agitation associated with Alzheimer’s disease.
The FDA set a Prescription Drug User Fee Act action date of April 30, 2026. AXS-05 is a combination of dextromethorphan hydrobromide and bupropion hydrochloride.
Agitation affects up to 76% of individuals with Alzheimer’s disease, and there are currently few approved treatment options, according to a Dec. 31 news release. The application is supported by data from four randomized, double-blind, controlled phase 3 trials and a long-term safety study.
The FDA previously granted AXS-05 breakthrough therapy designation for this indication in June 2020.
