Acceleration of the timeline for topline results from the MOMENTUM Phase III trial of AXS 07 for the acute treatment of migraine

Axsome Therapeutics announced the acceleration of the timeline for reporting topline results from the MOMENTUM Phase III trial of AXS 07 (MoSEIC meloxicam and rizatriptan), Axsome’s novel, oral, investigational medicine with distinct dual mechanisms of action for the acute treatment of migraine. The trial is being conducted pursuant to a FDA Special Protocol Assessment (SPA). The first patient was enrolled in the MOMENTUM trial in March 2019, and currently approximately 40% of the target number of patients have been randomized. Based on the faster-than-expected enrollment in this trial, topline results are now expected in the second half of 2019, versus previous guidance of the first quarter of 2020.

The MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase III trial is a randomized, double-blind, placebo- and active-controlled study of AXS 07 for the acute treatment of migraine, in which patients are randomized to treatment with AXS 07, rizatriptan, meloxicam, or placebo. Rizatriptan, the active comparator in the trial, is considered to be one of the most efficacious oral medications currently available for the acute treatment of migraine. The MOMENTUM trial is being enriched with difficult-to-treat patients because they represent a population for whom superior medicines are urgently needed. The rapid absorption and distinct dual mechanisms of action of AXS 07 provide a scientific rationale for potential success in providing relief for this more treatment resistant population.