AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared to placebo starting 1 week after treatment
NEW YORK, May 31, 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 the publication on May 30, 2022 of the results from the pivotal GEMINI Phase 3 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, “Efficacy and Safety of AXS-05 (dextromethorphan-bupropion) in Patients with Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI),” was published in The Journal of Clinical Psychiatry and is available in full here.
“The results published in The Journal of Clinical Psychiatry are consistent with strong and rapid antidepressant effects, and with a favorable safety profile with AXS-05,” said Maurizio Fava, MD, Psychiatrist-In-Chief, Department of Psychiatry, Massachusetts General Hospital, Executive Director, Clinical Trials Network & Institute, Associate Dean for Clinical & Translational Research, Slater Family Professor of Psychiatry, Harvard Medical School, and co-author of the publication. “Depression is a difficult-to-treat condition with potentially devastating consequences for patients and their families. Based on these results and its novel oral NMDA antagonist mechanism, AXS-05 may represent an important new treatment option for patients with depression.”
“We are very pleased with the publication of the pivotal GEMINI trial results in The Journal of Clinical Psychiatry, a leading scientific journal, less than two weeks after the publication of the pivotal ASCEND trial results in The American Journal of Psychiatry,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "These studies demonstrate a consistent efficacy profile for AXS-05 and form the basis of our NDA for the treatment of depression. If approved, we look forward to making AXS-05 available to Americans suffering from depression as soon as possible.”
The GEMINI trial assessed the efficacy and safety of AXS-05 versus placebo in patients with MDD. A total of 327 patients with a confirmed diagnosis of moderate to severe MDD were randomized to receive AXS-05 (45 mg dextromethorphan/105 mg bupropion tablet) (n=163), or placebo (n=164), once daily for the first 3 days and twice daily thereafter, for a total of 6 weeks. The primary endpoint was the change on the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week 6. The key secondary endpoints were the change from baseline in the MADRS total score at week 1, change from baseline in the MADRS total score at week 2, remission on the MADRS at week 2, and clinical response on the MADRS at week 6.
In the trial, AXS-05 demonstrated rapid, substantial, and statistically significant improvement in depressive symptoms and induction of remission compared with placebo. The change from baseline in MADRS score to week 6 was significantly greater with AXS-05 than with placebo (-15.9 points vs. -12.0 points; least-squares mean difference=-3.87; p=0.002). The MADRS score change with AXS-05 was significantly greater than placebo at week 1, the first timepoint, and at every timepoint thereafter (week 1: -7.20 vs. -4.97 points; least-squares mean difference=-2.23; p=0.007). Remission rates were significantly greater with AXS-05 at week 2 and every timepoint thereafter (week 6: 39.5% vs. 17.3%; treatment difference=22.2%; p