The study objective was to evaluate the efficacy and safety of AXS-07 versus rizatriptan, MoSEIC™ meloxicam and placebo in patients with a history of inadequate response to prior acute migraine treatments.

Migraine is highly disabling and more than 70% of patients are dissatisfied with current treatments. AXS-07 is a novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine.

This was a Phase 3, randomized, double-blind, placebo- and active-controlled study to assess the efficacy and safety of AXS-07 in the acute treatment of migraine. Eligible patients had to have a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire.

In total 1,594 patients were randomized (2:2:2:1) to receive a single dose of AXS-07, rizatriptan, MoSEIC™ meloxicam, or placebo to treat a migraine of moderate-to-severe pain intensity. The co-primary endpoints were headache pain freedom and absence of most bothersome symptom (MBS) two hours post-dosing, compared to placebo. Superiority over rizatriptan and MoSEIC™ meloxicam was assessed based on sustained pain freedom 2-24 hours post-dosing.

AXS-07 achieved the co-primary endpoints with statistically significant improvements versus placebo on pain freedom (19.9% vs. 6.7%, p<0.001) and absence of MBS (36.9% vs. 24.4%, p=0.002) 2 hours post-dosing. AXS-07 demonstrated superiority to rizatriptan and MoSEIC™ meloxicam on sustained pain freedom (16.1% vs. 11.2%, p=0.038, and 8.8%, p=0.001, respectively). AXS-07 provided rapid pain relief, demonstrating numerically greater relief than rizatriptan at all timepoints with statistical significance by 60 minutes post-dosing (p=0.04). A significantly lower proportion of patients used rescue medication with AXS-07 versus rizatriptan, meloxicam, and placebo (23.0% vs 34.7%, 35.1%, and 43.5%, respectively, p<0.001 each group). AXS-07 was safe and well-tolerated.

AXS-07 produced rapid, sustained, substantial and significant efficacy versus rizatriptan, MoSEIC™ meloxicam and placebo in the acute treatment of migraine in patients with a history of inadequate response.