Axsome's approved depression drug clears Alzheimer's agitation trial months after Lundbeck-Otsuka duo
After an August approval for treating major depressive disorder, Axsome Therapeutics’ tablet formulation of a cough suppressant and antidepressant has now cleared a Phase III in another indication.
The drug, known in MDD as Auvelity and under the investigational name AXS-05, was better than placebo at delaying the time for agitation relapse in patients with Alzheimer’s, the New York biotech said Monday morning. Topline data from the Phase III showed AXS-05 was statistically significant in delaying the time to relapse, with a p-value of 0.014.
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