Axsome Therapeutics completes phase 3 trials for AXS-05 in Alzheimer's agitation
- ACCORD-2 Phase 3 trial met primary endpoint, significantly delaying time to relapse of agitation compared to placebo (p=0.001).
- AXS-05 showed significant efficacy in three pivotal Phase 3 trials, with supportive safety data from a fourth trial.
- ADVANCE-2 trial did not achieve statistical significance for primary endpoint, but results favored AXS-05 over placebo.
- Axsome plans to submit a New Drug Application (NDA) to the FDA in the second half of 2025.
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