Safety and Tolerability of Rimegepant Every Other Day for Preventive Treatment of Migraine Plus As-Needed for Acute Treatment of Migraine: Results from A 52-Week, Open-Label Extension Phase (P12-12.006)
2023; Lippincott Williams & Wilkins; Volume: 100; Issue: 17_supplement_2 Linguagem: Inglês
10.1212/wnl.0000000000204207
ISSN1526-632X
AutoresRichard Lipton, David Kudrow, Timothy R. Smith, Jessica Ailani, Peter J. Goadsby, Lisa Kamen, Alexandra Thiry, Christopher Jensen, Robert Croop,
Tópico(s)Migraine and Headache Studies
ResumoObjective: Assess the safety and tolerability of rimegepant 75 mg dosed every other day (EOD) for the preventive treatment of migraine and as-needed (PRN) for acute treatment on nonscheduled dosing days. Background: Rimegepant is an orally administered small molecule CGRP receptor antagonist indicated for the acute and preventive treatment of migraine. Design/Methods: This open-label extension phase of a 12-week, phase 2/3, randomized, double-blind, placebo-controlled study (NCT03732638) included adults aged ≥18 years with a history of 4–18 moderate to severe monthly migraine attacks. Subjects completing 12 weeks of double-blind treatment with rimegepant 75 mg or placebo EOD could continue with rimegepant 75 mg EOD for preventive treatment of migraine for 52 weeks. On nonscheduled dosing days, subjects could take rimegepant 75 mg up to once per day PRN for acute treatment of migraine. Subjects who took ≥1 dose of open-label rimegepant were analyzed. Months were defined as 4-week intervals. Results: Of the 741 subjects who received double-blind treatment, 603 (81.4% [rimegepant n=301, placebo n=302]) were treated in the open-label extension. The most common AEs were upper respiratory tract infection (7.1%), nasopharyngitis (6.3%), and back pain (4.3%). The rate of discontinuation due to AEs was 2.8%. Serious AEs in 2.2% of subjects were considered not related to rimegepant. Two deaths (0.3%), 1 due to aortic dissection related to Marfan syndrome and 1 due to sepsis, were also deemed unrelated to rimegepant. Aminotransferases >3× the upper limit of normal (ULN) occurred in 3.4% of subjects; none had concurrent elevations in bilirubin >2× ULN. Subjects took a mean (SD) of 14.6 (2.45) rimegepant doses per month; 81.4% used ≤16 rimegepant tablets per month. Conclusions: One year of open-label rimegepant 75 mg dosed EOD for preventive treatment of migraine plus PRN on nonscheduled dosing days for acute treatment was safe and well tolerated, with no new safety concerns identified. Disclosure: 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 $500-$4,999 for serving as a Consultant for Satsuma. 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 Grifols. 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. 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 NIH. The institution of Dr. Lipton has received research support from NINDS. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIA. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from NIA. The institution of Dr. Lipton has received research support from NIH. The institution of Dr. Lipton has received research support from Veterans Administration. The institution of Dr. Lipton has received research support from NIH. Dr. Lipton has received publishing royalties from a publication relating to health care. 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 Amgen. 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 Novartis. 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 Biohaven. 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 Eli Lilly. 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 Lundbeck. Dr. Kudrow has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Kudrow has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Kudrow has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Kudrow has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Dr. Kudrow has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Kudrow has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. The institution of Dr. Smith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Nocira. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vorso/Nesos. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alder/Lundbeck. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. The institution of Dr. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. The institution of Dr. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurolief. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Nocira. The institution of Dr. Smith 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 Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. The institution of Dr. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie/Allergan. The institution of Dr. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. The institution of Dr. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Smith has stock in United Health Group. The institution of Dr. Smith has received research support from Aeon. The institution of Dr. Smith has received research support from Alder/Lundbeck. The institution of Dr. Smith has received research support from Alnylam. The institution of Dr. Smith has received research support from Amgen. The institution of Dr. Smith has received research support from Abbvie/Allergan. The institution of Dr. Smith has received research support from Biohaven. The institution of an immediate family member of Dr. Smith has received research support from Eliem Pharmaceuticals. The institution of Dr. Smith has received research support from Lilly. The institution of Dr. Smith has received research support from Pfizer. The institution of Dr. Smith has received research support from Nocira. The institution of Dr. Smith has received research support from Novo Nordisk. The institution of Dr. Smith has received research support from Teva. The institution of Dr. Smith has received research support from Theranica. The institution of Dr. Smith has received research support from Vorso/Nesos. Dr. Smith has a non-compensated relationship as a Board Member with National Headache Foundation that is relevant to AAN interests or activities. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck/Alder. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nesos. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiodeliveryScienceIndustry. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Ailani 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. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lindpharma. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Report. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Live. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Medscape. Dr. Ailani has stock in Ctrl M. The institution of Dr. Ailani has received research support from Allergan/Abbvie. The institution of Dr. Ailani has received research support from Eli Lilly. The institution of Dr. Ailani has received research support from Zosano. Dr. Ailani has received research support from Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Advisory Panel with Medscape. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Medical Advisor with SELF. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon BioPharmaceuticals. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli-Lilly. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Epalex. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Neuropharma. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr Reddys. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biodelivery Sciences International. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon Biopharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Massachusetts Medical Society. The institution of Dr. Goadsby has received research support from Celgene. The institution of Dr. Goadsby has received research support from Eli-Lilly. The institution of Dr. Goadsby has received research support from Visual Snow Initiative. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has a non-compensated relationship as a Trustee with Migraine Trust that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Trustee with Organisation for Understanding Cluster Headache (UK) that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Executive roles with American Headache Society that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Scientific Officer with British Association for the Study of Headache that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Director with American Migraine Foundation that is relevant to AAN interests or activities. Lisa Kamen has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc.. Lisa Kamen has received stock or an ownership interest from Biohaven Pharmaceuticals, Inc.. Alexandra Thiry has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Alexandra Thiry has received stock or an ownership interest from Biohaven Pharmaceuticals. Dr. Jensen has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Jensen has stock in Biohaven Pharmaceuticals. Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.
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