Publication of pivotal ASCEND phase II trial of AXS 05 in major depressive disorder in the American Journal of Psychiatry.
Axsome Therapeutics, Inc. announced the publication of the results from the pivotal ASCEND Phase II 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 was published in The American Journal of Psychiatry ( see citation below).
"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."
In the ASCEND trial, AXS 05 demonstrated rapid, substantial, and statistically significant improvement in depressive symptoms and induction of remission compared with bupropion. The mean change from baseline in MADRS score over weeks 1–6 was significantly greater with AXS 05 than with bupropion (-13.7 points vs. -8.8 points; least-squares mean difference=-4.9; p<0.001). the madrs score change with axs 05 was significantly greater than with bupropion at week 2 and every time point thereafter (week 6: -17.3 vs. -12.1 points; least-squares mean difference="-5.2;" p="0.013)." remission rates were significantly greater with axs 05 at week 2 and every time point thereafter (week 6: 46.5% vs. 16.2%; least-squares mean difference="30.3%;" p="0.004)." most secondary outcomes favored axs 05. axs 05 was generally well tolerated in the trial.
See: "Effect of AXS 05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial"-Herriot Tabuteau, M.D., Amanda Jones, Pharm.D., Ashley Anderson, B.S., Mark Jacobson, M.A., Dan V. Iosifescu, M.D.. American Journal of Psychiatry. Ahead of Print 18 May 2022.
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