ARTICLE | Product Development
Company looks to expand the label of depression drug AXS-05, while bringing Alzheimer’s agitation its second mechanism
By Selina Koch, Executive Editor, and Paul Bonanos, Director of Biopharma Intelligence
January 3, 2025 1:32 AM UTC
Only one drug is approved to treat agitation in Alzheimer’s patients. Axsome hopes to make AXS-05 the second, despite mixed results from its latest two Phase III trials in the indication.
Axsome Therapeutics Inc. (NASDAQ:AXSM) believes the totality of the evidence in its Phase III program supports an NDA submission next half. Although AXS-05 did not show statistical significance at improving disease scores in the ADVANCE-2 study, it has now led to significant improvements in the ADVANCE-1, ACCORD-1 and ACCORD-2 trials. ADVANCE-2 and ACCORD-2 delivered results on Dec. 30…
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- Source: https://www.biocentury.com/article/654600/axsome-to-lean-on-totality-of-data-in-alzheimer-s-agitation-submission