Abstract Details

Title 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.

Topic Headache

Presentation(s) P8 - Poster Session 8 (11:45 AM-12:45 PM)

Poster/Presentation
Number 15-014

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.

Authors/Disclosures
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache) PRESENTER	Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
Messoud Ashina, MD, PhD (Dept. of Neurology)	Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Incyte. The institution of Dr. Ashina has received research support from The Lundbeck Foundation. The institution of Dr. Ashina has received research support from Novo Nordisk Foundation . The institution of Dr. Ashina has received research support from Danish National Research Foundation . Dr. Ashina has received publishing royalties from a publication relating to health care.
Charly Gaul (Headache Center Frankfurt, Frankfurt am Main, Germany)	The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of an immediate family member of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vectura. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. The institution of Charly Gaul has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merz. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dr. Reddy. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Perfood. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Reckitt-Benckiser . The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Hormosan. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chordate. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Dr. Reddy. The institution of Charly Gaul has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie.
Adolfo Leyva Rendon	Adolfo Leyva Rendon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Adolfo Leyva Rendon has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer.
Luz M. Ramirez, MD	Dr. Ramirez has received personal compensation for serving as an employee of Pfizer.
Catherine Nalpas, PhD	Mrs. Nalpas has received personal compensation for serving as an employee of Pfizer. Mrs. Nalpas has stock in Pfizer. Mrs. Nalpas has stock in Janssen.
Alexandra Thiry, PhD	Dr. Thiry has received personal compensation for serving as an employee of Pfizer. Dr. Thiry has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Thiry has stock in Pfizer. Dr. Thiry has stock in Biohaven Pharmaceuticals.
Lucy Abraham (Pfizer R&D UK Ltd)	Lucy Abraham has received personal compensation for serving as an employee of Pfizer R&D UK Ltd. Lucy Abraham has stock in Pfizer R&D UK Ltd.
Robert Fountaine	Robert Fountaine has received personal compensation for serving as an employee of Pfizer, Inc.. Robert Fountaine has or had stock in Pfizer, Inc.Robert Fountaine has or had stock in Viatris, Inc.
Terence Fullerton, PharmD (Pfizer Global Product Development)	Dr. Fullerton has received personal compensation for serving as an employee of Pfizer. Dr. Fullerton has stock in Pfizer.

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