Phase 3 Trial of AXS-05 to Treat Agitation in Alzheimer’s Likely by Year’s End

Phase 3 Trial of AXS-05 to Treat Agitation in Alzheimer’s Likely by Year’s End
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 people with the disease. "Alzheimer’s disease agitation is very distressing to patients and their families," Herriot Tabuteau, MD, CEO of Axsome, said in a press release. "If successfully developed, AXS-05 has the potential to address this serious, prevalent, and debilitating condition, for which there is currently no approved treatment," Tabuteau added. AXS-05 has two active components: dextro
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