What do we already know about this topic?

• AXS-07 (MoSEIC™ meloxicam 20 mg/rizatriptan 10 mg) is a novel, oral, multi-mechanistic investigational medicine under development for the acute treatment of migraine.
• AXS-07 inhibits calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain signal transmission and central sensitization. ^1,2,3,4

How was this study conducted?

• MOMENTUM was a Phase 3 randomized, double-blind, placebo- and active-controlled multicenter study on adult patients with an inadequate response to prior acute migraine treatments (N=1,594).
• Patients were randomized in a 2:2:2:1 ratio to AXS-07 (MoSEIC™ meloxicam 20 mg/rizatriptan 10 mg), rizatriptan 10 mg, MoSEIC™ meloxicam 20 mg, or placebo, to treat a single (moderate or severe) migraine attack.
• Co-primary endpoints were pain freedom and freedom from most bothersome symptom (MBS) 2 hours after dosing for AXS-07 compared to placebo
• Secondary endpoint was sustained pain freedom from 2–24 hours after dosing.