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Axsome Therapeutics Initiates Phase 2/3 Trial of AXS-05 for Alzheimer’s Disease Agitation

Agitation reported in nearly 50% of patients with Alzheimer’s disease

FDA Fast Track designation previously received for AXS-05 for Alzheimer’s disease agitation

NEW YORK, July 17, 2017 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, enrolled the first patient in the ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) study, a Phase 2/3 trial evaluating the efficacy and safety of AXS-05 for the treatment of Alzheimer’s disease (AD) agitation. AXS-05 is a combination of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan).

“Agitation is one of the most distressing and difficult-to-treat behavioral symptoms in patients with Alzheimer’s disease,” said Jeffrey Cummings, M.D., Sc.D., Professor of Neurology, and Director of the Center for Neurodegeneration and Translational Neuroscience, at the Cleveland Clinic Lerner College of Medicine. “It is common, being reported in about half of patients, is one of the primary reasons for early nursing home placement, and is associated with increased mortality. NMDA receptor antagonism, sigma-1 receptor agonism, and serotonin and norepinephrine reuptake inhibition may be relevant mechanisms in this condition. New treatments are needed for agitation and progress in this area is a welcome advance.”

“Agitation places a heavy burden on patients with Alzheimer’s disease and their caregivers,” said Marc Agronin, M.D., Vice President of Behavioral Health and Clinical Research at Miami Jewish Health, and Affiliate Associate Professor of Psychiatry and Neurology at University of Miami Miller School of Medicine. “Unfortunately there is currently no FDA-approved medication for this condition. The mechanisms of action of AXS-05 may hold promise in treating Alzheimer’s agitation. We look forward to learning more about AXS-05 and its potential to relieve the symptoms of agitation through the ADVANCE-1 trial.”

“The initiation of the ADVANCE-1 trial reflects Axsome’s continued commitment to developing treatments for serious CNS disorders for which there are limited treatment options,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “The...