Efficacy and Safety of Symbravo® (MoSEIC(TM) Meloxicam and Rizatriptan) in Participants with Migraine Previously Treated with Oral CGRP Inhibitors: Topline Results from the EMERGE Trial
Richard Lipton1, Angad Chhabra2, Herriot Tabuteau2
1Department of Neurology and the Montefiore Headache Center, Albert Einstein College of Medicine, 2Axsome Therapeutics, Inc.
Objective:

The EMERGE trial evaluated the efficacy and safety of Symbravo® (MoSEICTM meloxicam and rizatriptan) in participants with a Migraine Treatment Optimization Questionnaire-4 (mTOQ-4) score ≤7 out of 8 (8=maximum treatment efficacy) while previously taking CGRP inhibitors (gepants). 

Background:

Symbravo was recently approved for the acute treatment of migraine. 

Design/Methods:
EMERGE (NCT05550207) was a Phase 3, open-label trial in adults with migraine. Participants had an mTOQ-4 score ≤7, including 1 or 0 for 2-hour pain freedom. Participants switched from gepants (used ≥1 month, ≥4 migraines before enrollment) to Symbravo for their next 4 migraines over ≤8 weeks. The primary endpoint was change in mTOQ-4 total score from baseline to end of Symbravo treatment. 
Results:

EMERGE enrolled 96 participants who treated 365 attacks with Symbravo. The trial met the primary endpoint, showing a significant improvement from baseline in mTOQ-4 score from baseline (5.2 vs 2.8, p<0.001). More participants achieved clinical response on each mTOQ-4 item with Symbravo versus baseline, including pain freedom at 2 hours for most attacks (47.9% vs 1.0%), ≥24-hour relief (47.9% vs 16.7%), ability to return to normal function (51.0% vs 11.5%), and comfort planning activities (63.5% vs 26.0%; all p<0.001). Across Symbravo-treated attacks, 2-hour pain relief and freedom were 50% and 22.5%; freedom from most bothersome symptom was 26.6%. Symbravo significantly improved quality of life and 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 common adverse events (≥2%) were fatigue, nausea, vomiting, muscle tightness, and dizziness. 

Conclusions:

In EMERGE, Symbravo was associated with significant improvements in outcomes in participants with an mTOQ-4 score ≤7 while previously taking gepants, including greater symptom relief, functional recovery, and quality of life. Together with prior studies, these findings support the efficacy of Symbravo across diverse patient populations.

10.1212/WNL.0000000000213261
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