Demonstrated statistical significance on regulatory co-primary endpoints of pain freedom (p<0.001) and freedom from most bothersome symptom (p=0.002) at 2 hours, compared to placebo
Demonstrated superiority to rizatriptan active comparator on key secondary endpoint of sustained pain freedom 2-24 hours after dosing (p=0.038)
Demonstrated greater and more sustained migraine pain relief than rizatriptan (p=0.006)
Rapidly relieved migraine pain; significantly reduced use of rescue medication compared to rizatriptan (p<0.001)
Positive results support NDA filing of AXS-07 in the acute treatment of migraine, anticipated in 2H 2020
Company to host conference call today at 8:00 AM ET
NEW YORK, Dec. 30, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, met the two regulatory co-primary endpoints and significantly improved migraine pain and most bothersome symptoms as compared to placebo in the MOMENTUM Phase 3 trial. AXS-07 also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain.