(58) Efficacy and Safety of Symbravo® (MoSEICTM meloxicam and rizatriptan) in Participants With Migraine Experiencing an Inadequate Response to Oral CGRP Inhibitors: Topline Results From the EMERGE Trial

Background: : Symbravo® (MoSEICTM meloxicam and rizatriptan [mMR]) was recently approved by the FDA for the acute treatment of migraine.

Objective: : To evaluate the efficacy and safety of mMR in the EMERGE study in patients experiencing an inadequate response to treatment with oral calcitonin gene-related peptide (CGRP) inhibitors (gepants).

Methods: : EMERGE (NCT05550207) was a Phase 3, open-label trial to evaluate the efficacy and safety of mMR for the acute treatment of migraine in adult participants experiencing inadequate response to a gepant. Inadequate response was defined as a score ≤7 on the Migraine Treatment Optimization Questionnaire-4 (mTOQ-4), including a score of 1 or 0 on the item assessing frequency of pain freedom 2 hours post-dose. Participants switched from gepants (used for ≥1 month and ≥4 migraines prior to enrollment) to mMR to treat their next 4 migraines over ≤8 weeks. The primary endpoint was change in mTOQ-4 total score from baseline (on gepants) to the end of mMR treatment.

Results: : EMERGE enrolled 96 participants, who treated 365 migraine attacks with mMR. The study met the primary endpoint, demonstrating a significantly improved mTOQ-4 total score with mMR vs baseline, (5.2 vs 2.8, p< 0.001). For each mTOQ-4 item, significantly more participants achieved a clinical response (score of 2 - “half of the time or more”) with mMR vs baseline. Pain freedom at 2 hours for most attacks was reported by 47.9% vs 1.0%, pain relief of ≥24 hours following a single dose of medication by 47.9% vs 16.7%, ability to return to normal function by 51.0% vs 11.5%, and feeling comfortable with medication to plan daily activities by 63.5% vs 26.0% (all p< 0.001). Across mMR-treated attacks, 2-hour pain relief and freedom were reported for 50% and 22.5%, respectively; freedom from the most bothersome symptom was reported for 26.6% at 2 hours.
Treatment with mMR led to a significant improvement in quality of life and daily functioning, assessed by the three domains of the Migraine-Specific Quality of Life Questionnaire (p=0.003 to < 0.001).
No new safety signals were observed. The most reported adverse events (≥2%) were fatigue (3.1%), nausea (3.1%), vomiting (2.1%), muscle tightness (2.1%), and dizziness (2.1%).

Conclusions: : In EMERGE, mMR was associated with significant improvements in migraine outcomes in participants with an inadequate response to gepants, including increased symptom relief, functional recovery, and quality of life. These results build upon findings from prior phase 3 studies, providing additional evidence for the efficacy of mMR in a range of patients with migraine.

Sponsorship:: Axsome Therapeutics, Inc.