Abstract Details

Title Oral Rimegepant 75 mg Is Well-tolerated When Used Concomitantly with Injectable Anti-CGRP Monoclonal Antibodies: Results From a Multicenter, Long-term, Open-label Safety Study

Topic Headache

Presentation(s) S8 - Migraine Therapeutics (4:54 PM-5:06 PM)

Poster/Presentation
Number 008

Objective Evaluate the safety and tolerability of oral rimegepant when used for acute treatment concomitantly with an injectable anti-CGRP monoclonal antibody (mAb) for preventive treatment in adults with migraine.

Background Calcitonin gene-related peptide (CGRP) is a therapeutic target in migraine, with small molecule CGRP receptor antagonists (gepants) developed initially for acute treatment and anti-CGRP mAbs for preventive treatment. Despite demonstrated efficacy of mAbs, most people still have attacks requiring acute treatment. Rimegepant is a small molecule CGRP receptor antagonist with demonstrated efficacy in the acute treatment of migraine. Safety of combined gepant-mAb use has not been assessed.

Design/Methods This was a multicenter, long-term, open-label safety study (Study 201) in adults with migraine with 2-14 migraine attacks of moderate to severe pain intensity per month. A 12-week treatment period was completed on a subgroup experiencing 2-8 moderate to severe monthly attacks while taking a stable dose of an FDA-approved anti-CGRP mAb. Rimegepant 75 mg orally was used as needed up to once daily for acute treatment.

Results Of the 13 subjects enrolled and receiving erenumab (n=7), fremanezumab (n=4), or galcanezumab (n=2), 10 (77%) completed the study. Mean (SD) age was 49.9 (13.69) years, and 11 (85%) were female. Mean (SD) time on treatment was 9.6 (4.57) weeks; rimegepant exposure per 4 weeks was 7.8 (5.54) doses. Five (38%) subjects reported ≥1 adverse event (AE). Of these, 2 subjects had nasopharyngitis; no other AEs occurred in ≥2 subjects. Three subjects had treatment-related AEs. No subjects had serious AEs, AEs leading to discontinuation, or ALT or AST levels ≥3x the upper limit of normal.

Conclusions Rimegepant 75 mg, when used as an oral acute treatment in subjects receiving injectable anti-CGRP mAbs as preventive treatment, demonstrated favorable tolerability and no safety issues in this sample of adults with migraine. Larger sample sizes are needed to confirm these findings.

Authors/Disclosures
Gary D. Berman, MD PRESENTER	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.
	No disclosure on file
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.
	No disclosure on file
	No disclosure on file
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
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.
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.
Robert Croop, MD	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.
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.

��ɫ��

��ɫ��