FDA's official communication or press release

Axsome Therapeutics Plans FDA NDA Submission for AXS-05 in Alzheimer’s Disease in 2H 2025 After Phase 3 Trials Show p=0.001

Dec 30, 2024, 12:40 PM

Axsome Therapeutics has announced plans to submit a New Drug Application (NDA) to the FDA for its Alzheimer’s disease treatment, AXS-05, in the second half of 2025. This decision follows the completion of a Phase 3 clinical program, which reportedly achieved its primary endpoint compared to placebo, with a p-value of 0.001 for time to relapse. However, the results from the ADVANCE-2 trial did not demonstrate statistical significance, although there were numerically greater improvements with AXS-05 over placebo in both primary and secondary endpoints. The mixed results from these trials have raised questions about the approvability of the data package by the FDA, but Axsome remains optimistic about moving forward.