Axsome Therapeutics is proceeding with submitting its Alzheimer’s disease treatment for FDA approval despite mixed results from two new clinical trials. Their drug AXS-05 met the primary endpoint in one trial for agitation caused by Alzheimer’s but did not show statistical significance in another. The drug delayed time to agitation episode relapse in one study but did not show a meaningful change in agitation scores in the second trial. Participants taking AXS-05 showed a 13.8-point reduction in agitation scores compared to 12.6 points in the placebo group. Despite these mixed results, Axsome is moving forward with the FDA submission.
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Axsome to send Alzheimer’s disease drug to FDA, despite mixed trial results
