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.

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.

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

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.