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# Priority Review for Axsome Alzheimer's Agitation Drugs
- URL: https://www.fdaweb.com/priority-review-for-axsome-alzheimers-agitation-drugs/
- Published: 2026-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:30:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160453

FDA has accepted for filing and granted a priority review to Axsome Therapeutics’ sNDA for AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation. The agency set 4/30 as the target PDUFA action date.

A company [statement](https://finance.yahoo.com/news/axsome-therapeutics-announces-fda-acceptance-120000279.html?ref=fdaweb.com) says the agency previously granted breakthrough therapy designation to AXS-05 in 6/2020 to treat Alzheimer’s disease agitation. It says the sNDA is the “culmination of a comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation, including four randomized, double-blind, controlled Phase 3 clinical trials and a long-term safety trial.”