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# Axsome Plans Alzheimer’s NDA on Mixed Data
- URL: https://www.fdaweb.com/axsome-plans-alzheimers-nda-on-mixed-data/
- Published: 2025-01-03T12:00:00.000Z
- Updated: 2026-09-14T14:49:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158417

Axsome Therapeutics says it will submit an NDA for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimer’s disease agitation despite reporting mixed Phase 3 clinical trial data. The investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor has previously been granted a Breakthrough therapy designation for the indication.

The company says its ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically delaying time to relapse of agitation, which was assessed by the Cohen-Mansfield Agitation Inventory (CMAI) total score. “AXS-05 also met the key secondary endpoint (relapse prevention, p=0.001),” it says. “Further, AXS-05 reduced worsening for overall Alzheimer’s disease severity compared to placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for Alzheimer’s disease (p<0.001).”

However, Axsome says its ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint — change in the CMAI total score from baseline to Week 5 (CMAI reductions of 13.8 and 12.6 points for AXS-05 and placebo, respectively). It further says that “results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo.”