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).
Symbravo was recently approved for the acute treatment of migraine.
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.
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.