Efficacy of Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) by Baseline Migraine-associated Disability: Post-hoc Analysis of the INTERCEPT Trial
Todd Grinnell1, Stewart Tepper2, Angad Chhabra1, Graham Eglit1, Herriot Tabuteau1
1Axsome Therapeutics, Inc., 2The New England Institute for Neurology and Headache
Objective:
This post-hoc analysis evaluated whether baseline migraine disability, assessed by the Migraine Disability Assessment (MIDAS) scale, influenced outcomes in the Phase 3 INTERCEPT trial of Symbravo® (MoSEICTM meloxicam and rizatriptan) for acute treatment of migraine.
Background:
In the Phase 3 INTERCEPT trial, Symbravo increased rates of freedom from pain and the most bothersome symptom (MBS) versus placebo, and improved rates of return to normal function at 2 hours.
Design/Methods:
Participants were adults with migraine averaging 2–8 attacks/month over the prior 3 months. They were randomized (1:1) to treat a single attack with Symbravo or placebo taken as soon as possible after migraine pain onset, while pain was mild. Participants were stratified by baseline MIDAS score: little/no (score ≤5), mild (6–10), moderate (11–20), or severe (≥21) disability. Ability to perform normal function, pain freedom, freedom from MBS, and rescue medication avoidance were analyzed.
Results:
Participants received Symbravo (n=132, mean age 41.6 years, 85.6% women) or placebo (n=135, 41.4 years, 85.2% women). Most reported moderate/severe disability at baseline (Symbravo n=108 [81.8%], placebo n=104 [78.8%]). Pre-treatment functional disability scores (0-3) were 1.3±0.67 (Symbravo) and 1.3±0.77 (placebo), indicating mild disability.
More participants could perform normal activity after 2 hours with Symbravo, with the greatest effects in the severe category (ARR vs placebo [95% CI]: 24.9% [9.6, 40.2]). More participants reported pain freedom at 2 hours post-dose with Symbravo (16.3% [6.1, 26.4]), with proportions consistent across subgroups. Freedom from MBS at 2 hours was more common in the severe (27.9% [11.8, 44.0]) vs lower disability subgroups, while avoidance of rescue medication was slightly more common in the mild subgroup (55.6% [32.6, 78.5]).
Conclusions:
In INTERCEPT, improvements in return to normal function with Symbravo were larger in participants with greater baseline disability, perhaps indicating a floor effect among those with minimal disability in the study population.
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