Axsome to send Alzheimer’s disease drug to FDA, despite mixed Phase 3 results

Axsome Therapeutics is moving ahead with plans to submit its Alzheimer’s disease treatment for Food and Drug Administration approval despite mixed results from two new clinical trial readouts.

Axsome, which is based in New York, announced Monday that its drug AXS-05 met the primary endpoint of one trial testing the therapy for agitation caused by Alzheimer’s, but failed to show statistical significance in another.

The drug delayed time to agitation episode relapse in one study, called ACCORD-2. But in the second trial, ADVANCE-2, the group of people taking AXS-05 didn’t show a meaningful change in their agitation scores, measured using a scoring system called the Cohen-Mansfield Agitation Inventory. Participants taking the drug showed a 13.8-point reduction in their agitation scores, compared to 12.6 points in the placebo group.

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