{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T22:19:48Z","timestamp":1793139588099,"version":"4.5.0"},"reference-count":22,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T00:00:00Z","timestamp":1711929600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Biohaven"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The present study evaluated the long-term safety and tolerability of rimegepant, an orally administered small molecule calcitonin gene-related peptide receptor antagonist, in people with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This multicenter, long-term, open-label safety study included adults (\u226518 years) with \u22651 year history of migraine who were sequentially enrolled into three groups: participants in the first two groups had either 2\u20138 or 9\u201314 moderate to severe migraine attacks per month by history and treated as needed ( pro re nata [PRN]) with one rimegepant 75\u2009mg oral tablet up to once per calendar day for 52 weeks (PRN 2\u20138 and PRN 9\u201314); a third group, included to collect safety data during higher-frequency dosing, had 4\u201314 moderate to severe migraine attacks per month by history and who took one rimegepant tablet every other day as scheduled dosing plus PRN dosing of one rimegepant tablet for migraine attacks of any severity on nonscheduled dosing days for 12 weeks (every other day (EOD)\u2009+\u2009PRN).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 1800 participants self-administered rimegepant (PRN 2\u20138: n\u2009=\u20091033; PRN 9\u201314: n\u2009=\u2009481; EOD\u2009+\u2009PRN: n\u2009=\u2009286). The most common on-treatment adverse events (AEs) were upper respiratory tract infection (8.8%), nasopharyngitis (6.8%) and sinusitis (5.1%). Most AEs were mild or moderate and considered unrelated to rimegepant. Serious AEs considered possibly (n\u2009=\u20091) or unlikely (n\u2009=\u20099) related to rimegepant were reported in ten (0.6%) participants. No signal of drug-induced liver injury because of rimegepant was identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Rimegepant 75\u2009mg up to once per day as EOD\u2009+\u2009PRN for 12 weeks or PRN for up to 52 weeks was safe and well tolerated. No signal of hepatotoxicity, potential drug abuse, or medication-overuse headache was identified. Trial registration: Clinicaltrials.gov: NCT03266588.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024241232944","type":"journal-article","created":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T02:46:16Z","timestamp":1714013176000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":48,"title":["A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine"],"prefix":"10.1177","volume":"44","author":[{"given":"Robert","family":"Croop","sequence":"first","affiliation":[{"name":"Biohaven Pharmaceuticals, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Berman","sequence":"additional","affiliation":[{"name":"Clinical Research Institute, Inc., Minneapolis, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Kudrow","sequence":"additional","affiliation":[{"name":"California Medical Clinic for Headache, Santa Monica, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"Mullin","sequence":"additional","affiliation":[{"name":"New England Institute for Neurology and Headache, Stamford, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Thiry","sequence":"additional","affiliation":[{"name":"Pfizer, Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meghan","family":"Lovegren","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilbert","family":"L\u2019Italien","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2652-2897","authenticated-orcid":false,"given":"Richard B","family":"Lipton","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine and the Montefiore Headache Center, Bronx, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,4,24]]},"reference":[{"key":"bibr1-03331024241232944","doi-asserted-by":"publisher","DOI":"10.1007\/s40266-019-00660-1"},{"key":"bibr2-03331024241232944","volume-title":"Analgesics for osteoarthritis: an update of the 2006 Comparative Effectiveness Review. 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Common Technical Criteria for Adverse Events (CTCAE) (version 5.0; 2017). Available at: https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/About.html (accessed 12 January 2024)."},{"key":"bibr19-03331024241232944","unstructured":"Division of AIDS. Table for grading the severity of adult and pediatric adverse events (corrected version 2.1; July 2017). Available at: https:\/\/rsc.niaid.nih.gov\/sites\/default\/files\/daidsgradingcorrectedv21.pdf (accessed 12 January 2024)."},{"key":"bibr20-03331024241232944","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2001.041007646.x"},{"key":"bibr21-03331024241232944","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252808.97649.21"},{"key":"bibr22-03331024241232944","unstructured":"Kwong J. Migraine Specific Quality of Life Questionnaire (MSQ v.2.1). 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