Axsome Therapeutics Announces Positive Efficacy and Safety Results from the Phase 3 MOVEMENT Long-Term Trial of AXS-07 in the Acute Treatment of Migraine

 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.

“The results of the open-label, Phase 3 MOVEMENT trial confirm in a real-world setting the strong efficacy of AXS-07 observed in our previous controlled trials, and demonstrate a favorable long-term safety profile,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “The rapid and substantial efficacy of AXS-07 now observed in three separate trials indicates that AXS-07 may provide unique benefits to patients with migraine and help address the current unmet need for more effective treatments. These data further support our planned NDA filing of AXS-07 in the acute treatment of migraine in the first quarter.”

The MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) trial evaluated the long-term safety of AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), dosed for up to 12 months, in patients with migraine attacks. The study enrolled patients who had completed the previous pivotal studies of AXS-07: the MOMENTUM and INTERCEPT trials. Enrolled patients were allowed to treat up to 10 migraine attacks per month during the up to 12-month period, with one dose of AXS-07 for each migraine that occurred. The safety and efficacy of AXS-07 was assessed during the trial. A total of 706 patients were enrolled. The trial was concluded once at least 300 patients had treated at least 2 migraines a month for 6 months, and approximately 100 patients had treated at least 2 migraines a month for 12 months, as pre-specified. At the time of study conclusion, 515 patients had reached at least 6 months, and 155 patients had reached at least 12 months of treatment. Over 21,000 migraine attacks were treated with AXS-07 during the trial.