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Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression
Rapid and substantial improvement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"Rapid and substantial improvement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment Rapid and substantial improvement in functioning achieved by 53% of patients at 2 weeks, 64% of patients at 6 weeks (Sheehan Disability Scale), and sustained with long-term treatment Marked or moderate improvement in depression achieved by 49% of patients at 2 weeks, 78% of patients at 6 weeks (Clinical Global Impression), and sustained with long-term treatment NEW YORK, Dec. 02, 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-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). Patients treated with AXS-05 experienced rapid, substantial, and durable improvements in depressive symptoms and functional impairment that was sustained with long-term treatment. The COMET-TRD trial evaluated 70 patients who had ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode. 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. AXS-05 treatment resulted in rapid, substantial, and durable improvement in depressive symptoms, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). Patients experienced a mean reduction from baseline in the MADRS total score of 10.4 points at Week 1, 14.7 points at Week 2, and 20.6 points at Week 6 (primary timepoint), with AXS-05 treatment. Clinical response on the MADRS (defined as ≥50% reduction in total score from baseline) after treatment with AXS-05 was achieved by 21.4% of patients at Week 1, 44.1% of patients at Week 2, and 67.2% of patients at Week 6. Remission from depression (defined as MADRS ≤10) after treatment with AXS-05 was achieved by 14.3% of patients at Week 1, 19.1% of patients at Week 2, and 43.8% of patients at Week 6. The improvement in depressive symptoms was sustained or increased with long-term treatment with AXS-05. Patients experienc...