Axsome Therapeutics, Inc. announced that its Investigational New Drug Application (IND) for AXS-05 in the treatment of agitation in patients with Alzheimer’s disease (AD) has been cleared by the U.S. Food and Drug Administration (FDA). The IND clearance permits Axsome to proceed with its planned Phase 2/3 clinical trial of AXS-05 in this indication. Axsome anticipates commencing this trial in the first half of 2017. The planned Phase 2/3 trial is a multicenter, randomized, double-blind, placebo-controlled study to examine the efficacy and safety of AXS-05 in AD patients with agitation. Approximately 330 subjects will be randomly assigned to treatment with AXS-05, placebo, or bupropion, which is one of the components of AXS-05.