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Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry
In this study, AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared with the
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"In this study, AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared with the active comparator bupropion \nNEW YORK, May 18, 2022 /PRNewswire/ -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the publication of the results from the pivotal ASCEND Phase 2 clinical trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). AXS-05 is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity. The article, \"Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized, Double-Blind, Controlled Trial,\" was published today in The American Journal of Psychiatry and is available in full here.\n\n \n \n \n \n \n \n\n \n\"Major depressive disorder is highly prevalent, debilitating and potentially life-threatening. There is an urgent need for mechanistically new treatments that are effective and well tolerated,\" said Dan Iosifescu, MD, Professor of Psychiatry at the New York University School of Medicine, Director of the Clinical Research Division at the Nathan Kline Institute for Psychiatric Research, and co-author of the publication. \"Due to its novel mechanism of action targeting glutamate and sigma-1 receptors, and to its robust antidepressant efficacy demonstrated in this study, AXS-05 has the potential to become an important and very useful new treatment for patients with major depressive disorder.\"\n\"We are very pleased with the publication of the ASCEND trial results in The American Journal of Psychiatry, the most widely read psychiatric journal in the world1,\" said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. \"ASCEND is one of the pivotal efficacy trials that forms the basis of our NDA for AXS-05 in depression, which is currently under review by the FDA. Axsome is positioned to move expeditiously to make this product available to patients as quickly as possible, should it be approved.\"\nThe ASCEND trial assessed the efficacy and safety of AXS-05 versus the active comparator bupropion in patients with MDD. A total of 80 patients with a diagnosis of moderate to severe MDD, confirmed by an independent ...