Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine
Significantly faster time to pain relief as compared to rizatriptan (p<0.001)
Significantly less relapse of migraine pain as compared to rizatriptan (p=0.001)
Benefits demonstrated in patients with a history of inadequate response to prior acute treatments
NEW YORK, September 24, 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 that AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial. These findings were presented at the live sessions of the 2020 American Academy of Neurology (AAN) Science Highlights platform held virtually September 23-24.
The MOMENTUM study 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. 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. 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 [1-3].
AXS-07 demonstrated faster and more durable relief of migraine pain as compared to rizatriptan. The probability of achieving pain relief with AXS-07 was greater than with rizatriptan within 30 minutes after dosing and at every time point thereafter, with a median time to migraine pain relief that was nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0 hours, p<0.001). AXS-07 substantially and significantly reduced relapse of migraine pain as compared to rizatriptan, with 45.2% of rizatriptan-treated patients experiencing relapse compared to 21.2% of AXS-07 patients over 48 hours after dosing (p=0.001).
The results on time to migraine pain relief and relapse are consistent with the superiority of AXS-07 over rizatriptan on several other efficacy measures, as previously reported, including rescue medication use (p<0.001), sustained pain relief over 24 hours (p=0.006) and 48 hours (p=0.003), sustained pain freedom over 24 hours (p=0.038) and 48 hours (p=0.003), Patient Global Impression of Change (p=0.022) at 2 hours, and return to normal functioning at 24 hours (p=0.027). Also as previously reported, AXS-07 met both co-primary endpoints of the trial by demonstrating a greater percentage of patients achieving pain freedom (p<0.001) and absence of most bothersome symptom (p=0.002), 2 hours after dosing, as compared to placebo.
"The strong efficacy of AXS-07 in patients with a history of inadequate response is especially notable since it was demonstrated over one of the most effective triptans,” said Cedric O’Gorman, MD, Senior Vice President of Clinical Development and Medical Affairs of Axsome. “With its demonstrated rapid, superior, and durable effects in the acute treatment of migraine, AXS-07 may help address the need for more efficacious treatments for this debilitating neurological condition.”
AXS-07 was safe and well tolerated in the trial. The most commonly reported adverse events with AXS-07 were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%.
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. AXS-07 is thought to act by inhibiting CGRP release, reversing CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain signal transmission, and central sensitization. Axsome’s MoSEIC™ technology significantly increases the speed of absorption of the meloxicam component after oral administration while maintaining a long plasma half-life. AXS-07 is covered by 44 issued U.S. and international patents providing protection out to 2036, and Axsome maintains worldwide rights.
