Business
Axsome Therapeutics Announces Positive Efficacy and Safety Results from Phase 3 COMET Long-Term Trial and COMET-AU Trial of AXS-05 in Major Depressive Disorder
Rapid and substantial improvement in depressive symptoms achieved by 40% of patients at 2 weeks, 73% at 6 weeks (MADRS response), and sustained over 12 months
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"Rapid and substantial improvement in depressive symptoms achieved by 40% of patients at 2 weeks, 73% at 6 weeks (MADRS response), and sustained over 12 months\n Rapid and substantial improvement in functioning achieved by 55% of patients at 2 weeks, 71% at 6 weeks (Sheehan Disability Scale), and sustained over 12 months Marked or moderate improvement in depression achieved by 50% of patients at 2 weeks, 83% at 6 weeks (Clinical Global Impression), and sustained over 12 months Efficacy in patients failing one prior antidepressant similar to overall results Long-term safety profile consistent with previously completed controlled trials, with no new safety signals detected NDA on track for submission in January 2021 NEW YORK, Dec. 01, 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 long-term, open-label Phase 3 COMET trial of AXS-05 in patients with major depressive disorder (MDD), and the open-label Phase 2 COMET-AU trial in patients failing one prior antidepressant treatment. AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. Patients treated with AXS-05 in these trials experienced rapid, substantial, and durable improvements in depressive symptoms and functional impairment that was sustained over the 12-month treatment period. AXS-05 was well tolerated over the long-term treatment period with a safety profile consistent with what was observed in the previously reported controlled trials in terms of frequency and type of adverse events, with no new safety signals detected. Axsome remains on track to submit an NDA for AXS-05 in the treatment of MDD in January 2021. “The data from the open-label Phase 3 COMET trial indicate that AXS-05 treatment is associated with rapid improvement in both depressive symptoms and related functional impairment that are sustained with long-term treatment and accompanied by a favorable safety profile,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Results from the open-label Phase 2 COMET-AU trial further indicate that the treatment benefits with AXS-05 were also substantial in patients who were unresponsive to a prior antidepressant. Overall, the short and long-term ef...