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Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT ...
Axsome Therapeutics, Inc.December 31, 2020 GMT
Over 21,000 migraine attacks treated with AXS-07
Achieved migraine pain relief in approximately 70% of patients, and pain freedom in approximately 40% of patients, at 2 hours
Achieved durable relief, with approximately 85% of patients free from rescue medication use over 48 hours
Long-term safety profile consistent with previously completed controlled trials
NDA on track for submission in 1Q 2021
NEW YORK, Dec. 31, 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 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. AXS-07 was well tolerated over long-term treatment with a safety profile consistent with that observed in the previously reported controlled trials. Axsome remains on track to submit an NDA for AXS-07 in the acute treatment of migraine in the first quarter of 2021.