Safety and Effectiveness of Rimegepant for Acute Treatment of Migraine in Adults Unsuitable for Triptan Use: Results from a 12-week Open-label Extension Phase.
Messoud Ashina1, Peter McAllister2, Charly Gaul3, Adolfo Leyva-Rendon4, Luz M Ramirez5, Catherine Nalpas5, Alexandra Thiry5, Lucy Abraham6, Robert Fountaine5, Terence Fullerton5
1Danish Headache Center, Rigshospitalet, 2New England Institute for Neurology and Headache, 3Headache Center Frankfurt, 4National Institute of Neurology and Neurosurgery, 5Pfizer Inc, 6Pfizer R&D UK Ltd
Objective:
To evaluate safety and attack-to-attack reliability of rimegepant (RIM) for acute treatment of migraine over 12 weeks in adults unsuitable for triptans, and to explore changes in monthly migraine days (MMDs).
Background:
A randomized, double-blind (DB), placebo-controlled trial demonstrated efficacy of RIM for acute treatment of migraine in adults unsuitable for triptans due to history of intolerance or lack of efficacy to ≥2 triptans, or contraindication (NCT05509400). Conclusions were limited given the use of one dose of RIM to treat a single attack.
Design/Methods:
This was a 12-week open-label (OL) extension of study NCT05509400. Participants treated attacks of moderate or severe pain intensity with RIM 75 mg orally disintegrating table (ODT) as needed (PRN), up to once per day. Safety was assessed by adverse events (AEs). Efficacy endpoints included: (1) reliability of RIM effect, (2) mean change from historical baseline (HBL) in MMDs, and (3) percentage of participants with ≥50% reduction from HBL in MMDs. Reliability was defined as response rates for ≥4 of the first 5 evaluable qualifying migraine attacks (EQMAs) ≥23 hours apart during the OL phase being no more than 7% less than the single EQMA rate for RIM participants in the DB phase. Response was defined as migraine symptoms "moderately or very much better" at 24 h post-dose.
Results:
552 participants took OL RIM and 94.0% completed the OL phase. Severe AEs (0.5%), serious AEs (0.4%), and AEs leading to RIM discontinuation (0.9%) were infrequent. Reliability of RIM effect was met: response was 64.2% for the DB EQMA and 65.1%–71.1% across the first 5 OL EQMAs. Mean (SD) change in MMDs was −2.8 (3.3) days and 38.9% of participants achieved ≥50% reduction.
Conclusions:
In triptan-unsuitable adults, RIM 75 mg ODT PRN for up to 12 weeks demonstrated favorable safety, stable population-level effects across repeated attacks, and fewer MMDs.
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