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Axsome Therapeutics Announces Availability of AUVELITY™, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults
AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"AUVELITY is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week1-4 Auvelity On My Side offers comprehensive patient support services including access and prescription drug support NEW YORK, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that AUVELITY™ (dextromethorphan HBr-bupropion HCl) is now available by prescription in the United States for the treatment of major depressive disorder (MDD) in adults.1 AUVELITY is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD, and the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.1-4 AUVELITY was developed with FDA Breakthrough Therapy designation for the treatment of MDD. Rakesh Jain, MD, Clinical Professor, Department of Psychiatry, of Texas Tech University School of Medicine said, “Auvelity may shift the way physicians approach the treatment of patients experiencing major depressive disorder due to its differentiated clinical profile. Auvelity utilizes the first new oral non-monoamine-based mechanism of action in more than six decades approved for the treatment of major depressive disorder in adults. Based on its demonstrated rapid action starting at one week versus placebo, and its sustained effect, Auvelity represents an important new treatment for patients suffering from this debilitating and potentially life-threatening condition.” Michael Pollock, Chief Executive Officer of the Depression and Bipolar Support Alliance (DBSA), a leading national patient advocacy organization focusing on depression and bipolar disorder said, “Our community of peers and their physicians welcome any new innovations that can improve the experience of patients living with depression. More than 20 million American adults experienced major depressive disorder each year prior to the COVID-19 pandemic, and the prevalence increased dramatically during the pandemic with more than 80 million Americans experiencing elevated depr...