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Axsome Therapeutics Announces Positive Results from the COMET-SI Trial of AXS-05 in Patients with Major Depressive Disorder Who Have Suicidal Ideation
68% reduction in MADRS Suicidality Item score by Week 1, and 82% reduction by Week 4 Resolution of suicidal ideation achieved by 60% of patients by Week 1,
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"68% reduction in MADRS Suicidality Item score by Week 1, and 82% reduction by Week 4 Resolution of suicidal ideation achieved by 60% of patients by Week 1, and 78% by Week 4 Effects consistent with new integrated data from AXS-05 controlled trials demonstrating reduction in MADRS Suicidality Item score versus control, at Week 1 (p=0.001) Rapid and substantial improvement in functioning achieved by 51% of patients at Week 1 and 77% of patients at Week 6 (Sheehan Disability Scale) NEW YORK, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-SI trial of AXS-05 in patients with major depressive disorder (MDD) who have suicidal ideation (SI). Patients treated with AXS-05 experienced rapid reduction of suicidal ideation, rapid functional improvement, and rapid, substantial, and durable improvements in overall depressive symptoms. The COMET-SI trial evaluated 37 patients with suicidal ideation, defined as a score of ≥3 on the Suicidality Item of the Montgomery-Åsberg Depression Rating Scale (MADRS-SI), at baseline. Patients were treated with AXS-05 (45 mg dextromethorphan-105 mg bupropion modulated delivery tablet) twice daily for up to 12 months. AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. A rapid reduction in suicidal ideation was observed with AXS-05 treatment, as demonstrated by reductions in the MADRS-SI score of 67.6% by Week 1, the earliest time point measured, 73.5% by Week 2, and 82.4% by Week 4. Resolution of suicidal ideation with AXS-05 treatment was achieved by 60.0% of patients by Week 1, 68.8% by Week 2, and 77.8% of patients by Week 4. Resolution was defined as a MADRS-SI score of 0 or 1 on a 0 to 6 scale. The effect of AXS-05 on suicidal ideation in the open-label COMET-SI trial is consistent with new controlled data from the previously completed placebo-controlled GEMINI and active-controlled ASCEND trials of AXS-05 in the treatment of MDD. Integrated analysis from these trials demonstrated rapid reduction in MADRS-SI scores with AXS-05 compared to placebo or active control, which was statistically significant at Week 1, the earliest time point assessed (p=0.001 ver...