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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.
“Agitation, including aggression, is seen in a significant percentage of patients with Alzheimer’s disease, leads to early nursing home placement, accelerates cognitive decline, and increases the risk of death,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome Therapeutics. “We look forward to examining the potential of AXS-05 to treat this distressing condition for which there is currently no approved treatment. The successful filing and FDA clearance of this IND is a key milestone for Axsome and marks the second open IND for AXS-05.”
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. The primary endpoint of the trial will be assessed using the Cohen-Mansfield Agitation Inventory.
AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the FDA.
