Axsome Therapeutics announced data from the Phase 3 MOMENTUM trial evaluating AXS-07 in the acute treatment of migraine was selected as a featured presentation at the 2020 American Academy of Neurology (AAN) Science Highlights platform, to be held virtually September 23, 2020. The AAN Science Committee reviewed over 150 late-breaking, or Emerging Science, abstracts and selected 12 to be featured presentations on the new 2020 AAN Science Highlights platform. The results of the Phase 3 MOMENTUM trial were one of the 12 selected abstracts.
Axsome reported data from MOMENTUM in December of 2019. 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. Rizatriptan was used as an active comparator in the trial, as it is one of the most effective medications currently available for the acute treatment of migraine.
AXS-07 met the two co-primary endpoints by demonstrating, with high statistical significance, a greater percentage of patients as compared to placebo achieving pain freedom (19.9% versus 6.7%) and absence of most bothersome symptom (36.9% versus 24.4%), two hours after dosing. Superiority of AXS-07 to rizatriptan and MoSEIC meloxicam (component contribution) was established by demonstration of a greater percentage of AXS-07 patients achieving sustained pain freedom from 2 to 24 hours after dosing, compared to rizatriptan and MoSEIC meloxicam, as well as to placebo (16.1%, 11.2%, 8.8% and 5.3%, respectively).
AXS-07 is a novel, oral, multi-mechanistic medicine. AXS-07 consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence.