Drug for Treatment of Major Depressive Disorder Announces Positive Trial Results


Axsome Therapeutics released details from their COMET-SI trial for AXS-05, an oral investigational NMDA receptor.


Axsome Therapeutics announced positive results from the open-label Phase 2 trial of their oral investigational NMDA receptor, AXS-05, for the treatment of patients with major depressive disorder (MDD) who have suicidal ideation. Participants treated with AXS-05, a dextromethorphan-bupropion modulated delivery tablet, saw a rapid decrease in suicidal thoughts, functional improvement, and an overall decrease in depressive symptoms.

“These early data are the first for AXS-05 in major depressive disorder patients with suicidal ideation, and highlight the rapid onset of action of AXS-05, observed by the first week, on clinically important measures in this serious condition,” Herriot Tabuteau, MD, Chief Executive Officer of Axsome, said to the press. “The results of the COMET-SI trial suggest that AXS-05, as an oral NMDA receptor antagonist, may provide unique benefits to patients by potentially rapidly and durably improving not only suicidal thoughts but also functional impairment associated with depression. These positive effects expand on and are consistent with the differentiated clinical profile of AXS-05 observed in our completed controlled trials in patients with major depressive disorder.”1

The COMET-SI trial comprised of 37 participants with suicidal ideation, defined as a score of ≥3 on the Suicidality Item of the Montgomery-Åsberg Depression Rating Scale (MADRS-SI), at baseline. Treated twice daily, participants continued the study for up to 12 months.

Resolution of suicidal ideation was achieved in week 1 by 60% of the participants, in week 2 by 68.8% of the participants, and in week 4 by 77.8% of the participants. Marked or moderate improvements in depressive symptoms were achieved 40% of participants in week 1, 59.4% of participants in week 2, and 69.2% of participants in week 6.

AXS-05 was well tolerated, the safety profile consistent with previous reports from other trials of AXS-05 in MDD. The most common adverse events were dizziness, nausea, headache, dry mouth, and decreased appetite.


1. Axsome Therapeutics. Axsome Therapeutics Announces Positive Results from the COMET-SI Trial of AXS-05 in Patients with Major Depressive Disorder Who Have Suicidal Ideation. News release. GlobeNewswire. December 8, 2020. https://www.globenewswire.com/news-release/2020/12/08/2141143/0/en/Axsome-Therapeutics-Announces-Positive-Results-from-the-COMET-SI-Trial-of-AXS-05-in-Patients-with-Major-Depressive-Disorder-Who-Have-Suicidal-Ideation.html

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