EMERGE Study: An Open-label Evaluation of the Efficacy and Safety of AXS-07 (MoSEIC™ meloxicam-rizatriptan) for Migraine in Adults with Prior Inadequate Response to an Oral CGRP Inhibitor
Peter McAllister1, Stewart Tepper2, Angad Chhabra3, Caroline Streicher3, Gregory Parks3, Herriot Tabuteau3
1New England Inst for Neurology and Headache, 2Geisel School of Medicine At Dartmouth, 3Axsome Therapeutics
Objective:
To describe the EMERGE (NCT05550207) trial; a phase 3 multi-center open-label trial evaluating the efficacy and safety of AXS-07 in the acute treatment of migraine headache in adults with a prior inadequate response to an oral calcitonin gene-related peptide (CGRP) inhibitor.
Background:

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine, consisting of MoSEIC™ meloxicam and rizatriptan. Meloxicam is enabled by MoSEIC™ technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a potent, COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5 HT1B/1D agonist. AXS-07 has demonstrated efficacy for the acute treatment of migraine in two clinical trials:  MOMENTUM and INTERCEPT.

Design/Methods:

The EMERGE trial is enrolling participants with a history of migraine attacks and prior inadequate response to oral CGRP inhibitors as defined by the Migraine Treatment Optimization Questionnaire (mTOQ-4). The mTOQ-4 is a validated questionnaire that assesses treatment efficacy. Patients will be treated with AXS-07 for up to 8 weeks or 4 migraine attacks. Participants must be at least 18 years of age, have a diagnosis of migraine with or without aura and experience 2 to 8 migraine attacks per month. Participants must have been using an oral CGRP inhibitor (rimegepant or ubrogepant).  The co-primary efficacy endpoints are the percentage of participants with headache pain relief at Hour 2 and absence of the most bothersome symptom (MBS) at Hour 2, without the use of rescue medication.

Results:

Enrollment began in August 2022. Target enrollment is 100 participants.  Study results are expected in 2024.

Conclusions:

This is the first study to investigate the effects of AXS-07 in patients with inadequate response to oral CGRP inhibitors, a difficult to treat patient population.

10.1212/WNL.0000000000205841