Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response

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.

MOMENTUM was a randomized, double-blind, placebo- and active-controlled trial which enrolled only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4). A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), rizatriptan (10 mg), MoSEIC meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. In addition to a history of inadequate response, enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes including cutaneous allodynia (75.4%), severe migraine pain intensity (41.2%), obesity (43.7%), and morning migraine (36.6%). The study was conducted pursuant to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). Rizatriptan, an active comparator in the trial, is considered to be the fastest acting oral triptan and one of the most effective medications currently available for the acute treatment of migraine [1].