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Axsome Therapeutics Announces Completion of Patient Enrollment in the GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder
NEW YORK, Oct. 16, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Oct. 16, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the completion of patient enrollment in the GEMINI study, a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-05 in patients with major depressive disorder (MDD). AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. Axsome remains on track to report topline results from GEMINI in the fourth quarter of 2019.\n About the GEMINI Trial GEMINI (Glutamatergic and Monoaminergic Modulation in Depression) is a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial of AXS-05 in patients with major depressive disorder (MDD). Approximately 300 patients with a confirmed diagnosis of moderate to severe MDD will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks. Assessments including the Montgomery-Åsberg Depression Rating Scale (MADRS), safety parameters, clinician-rated scales, as well as patient-reported outcome measures will be conducted throughout the study. About Major Depressive Disorder (MDD) Major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, and which impairs social, occupational, educational, or other important functioning. In severe cases, MDD can result in suicide. According to the National Institutes of Health, an estimated 7.1% of U.S. adults, or approximately 17.3 million, experience MDD each year1. According to the World Health Organization (WHO), depression is the leading cause of disability worldwide, and is a major contributor to the overall global burden of disease2. Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy3, highlighting the need for additional therapies with new mechanisms of action. The majority of patients who initially fail also fail second-line treatment. Patients diagnosed with MDD are defined as having treatment resistant depression (TRD) if they have fa...