Axsome Therapeutics announced plan to soon open a Phase 3 clinical trial of AXS-05, its investigational oral treatment for Alzheimer’s disease-related agitation, after U.S. Food and Drug Administration (FDA) officials confirmed an earlier study was pivotal. Results from this new efficacy trial, to open before year’s end, are expected to support a new drug application (NDA) seeking regulatory approval of AXS-05 from the FDA. Feelings of agitation are common symptoms of Alzheimer’s, experienced by up to three-quarters of…
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