Abstract Details

Title Long-Term Safety of Rimegepant 75 mg for the Acute Treatment of Migraine (Study 201)

Topic Headache

Presentation(s) S58 - Headache Therapeutics (2:36 PM-2:48 PM)

Poster/Presentation
Number 009

Objective Evaluate the long-term safety of rimegepant 75 mg dosed up to once daily for up to 52 weeks.

Background Rimegepant is a small molecule CGRP receptor antagonist with demonstrated efficacy in the acute treatment of migraine. Final results from this long-term safety study have not previously been reported.

Design/Methods This was a multicenter, long-term, open-label safety study (Study 201) of rimegepant in adults with a history of 2-14 monthly migraine attacks of moderate to severe intensity. Subjects used rimegepant 75 mg orally up to once daily PRN to treat attacks of any pain intensity for up to 52 weeks. A subgroup with 4-14 moderate to severe monthly attacks was assigned to rimegepant 75 mg QOD scheduled dosing for 12 weeks supplemented by PRN dosing (QOD+PRN) on nonscheduled dosing days.

Results In total, 1,800 subjects were treated (PRN [n=1514], QOD+PRN [n=286]). Most subjects (89.4%) were female; median age was 43 years and 3.7% were ≥65 years. Overall, 112,014 rimegepant doses were administered. On-treatment adverse events (AEs) were reported in 60.4% of subjects; the most common (≥5%) were upper respiratory tract infection (8.8%), nasopharyngitis (6.8%), and sinusitis (5.1%). Overall, 2.7% of subjects discontinued due to an AE. Serious AEs were reported in 47 (2.6%) subjects; none were considered by the investigator to be related. Overall, 1.0% of subjects experienced ALT or AST levels >3x ULN during treatment; no cases were assessed as probably related to rimegepant by an external panel of liver experts; there were no Hy’s law cases. In the 12-week QOD+PRN cohort (n=286), no rimegepant-treated subjects experienced ALT or AST levels >3x ULN or bilirubin levels >2x ULN during treatment (n=279).

Conclusions This open-label safety study in adults with migraine shows that long-term dosing of rimegepant 75 mg up to once daily is well-tolerated with a favorable safety profile and no signs of hepatotoxicity.

Authors/Disclosures
Robert Croop, MD PRESENTER	Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Collima LLC. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has stock in Actio Biosciences, Inc. . Dr. Croop has received research support from Pfizer Inc. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.
Gary D. Berman, MD	Dr. Berman has received personal compensation for serving as an employee of Clinical Research Institute. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder. Dr. Berman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Berman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergen. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven.
David B. Kudrow, MD (David Kudrow MD)	Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Kathleen B. Mullin, MD (NEINH)	Dr. Mullin has received personal compensation in the range of $0-$499 for serving as a Consultant for Vorso. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Mullin has received personal compensation in the range of $0-$499 for serving as a Consultant for Theranica. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Elyse Stock	Elyse Stock has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Flagship Pioneering Management. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol-Myers Squibb. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Optinose. An immediate family member of Elyse Stock has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abpro. An immediate family member of Elyse Stock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Adagio. Elyse Stock has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Biohaven Pharmaceuticals. Elyse Stock has received stock or an ownership interest from Biohaven Pharmaceuticals. An immediate family member of Elyse Stock has received stock or an ownership interest from BIohaven Pharmaceuticals.
	No disclosure on file
Charlie Conway	Charlie Conway has received personal compensation for serving as an employee of Biohaven Pharmaceuticals Inc. Charlie Conway has received stock or an ownership interest from Biohaven Pharmaceuticals.
Christopher Jensen, PharmD (Biohaven Pharmaceuticals)	Dr. Jensen has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Jensen has stock in Biohaven Pharmaceuticals.
	No disclosure on file
Vladimir Coric	Vladimir Coric has received personal compensation for serving as an employee of Biohaven. Vladimir Coric has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Bioahven. Vladimir Coric has stock in Biohaven. Vladimir Coric has received intellectual property interests from a discovery or technology relating to health care.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.

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