{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T00:05:26Z","timestamp":1793145926837,"version":"4.5.0"},"reference-count":24,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Zavegepant is the first small molecule calcitonin gene-related peptide receptor antagonist for intranasal administration for the acute treatment of migraine. The objective of this study was to evaluate the safety and tolerability of zavegepant in the acute treatment of migraine under repeated, as-needed dosing for up to one year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This phase 2\/3, one-year open-label safety study of zavegepant 10\u2005mg nasal spray for the acute treatment of migraine enrolled adults aged \u226518 years with a history of two to eight moderate to severe monthly migraine attacks. Participants used one dose of zavegepant as needed to self-treat migraine attacks of any severity, up to eight times per month, for 52 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Participants were enrolled between 29 June and 4 December 2020. Of the 608 participants entering long-term treatment, 603 were treated with study drug. Participants administered a mean (SD) of 3.1 (1.55) zavegepant doses per month. There were no deaths. Of the seven serious adverse events reported, none was considered related to treatment. Altogether, 6.8% (41\/603) of treated participants had an adverse event leading to study drug discontinuation. The most frequent adverse event leading to discontinuation was dysgeusia (1.5% [9\/603]). The most common treatment-emergent adverse events (\u22655% of participants) were dysgeusia (39.1% [236\/603]); nasal discomfort (10.3% [62\/603]); COVID-19 (7.5% [45\/603]); nausea (6.1% [37\/603]); nasal congestion and throat irritation (5.5% [33\/603] each); and back pain (5.3% [32\/603]). Aminotransferases &gt;3x the upper limit of normal occurred in 2.6% [16\/603] of participants; none had concurrent elevations in bilirubin &gt;2x upper limit of normal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>One year of zavegepant 10\u2005mg nasal spray up to eight times per month was safe and well tolerated. Trial registration: Clinicaltrials.gov: NCT04408794<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024241259456","type":"journal-article","created":{"date-parts":[[2024,8,30]],"date-time":"2024-08-30T03:58:09Z","timestamp":1724990289000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":16,"title":["Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2\/3 open-label study"],"prefix":"10.1177","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-7076-3497","authenticated-orcid":false,"given":"Kathleen","family":"Mullin","sequence":"first","affiliation":[{"name":"New England Headache Center, Stamford, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Croop","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals, New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Mosher","sequence":"additional","affiliation":[{"name":"Pfizer Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terence","family":"Fullerton","sequence":"additional","affiliation":[{"name":"Pfizer Inc., New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Madonia","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, Bronx, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,8,30]]},"reference":[{"key":"bibr1-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.55.6.754"},{"key":"bibr2-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/head.12499"},{"key":"bibr3-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/head.14153"},{"key":"bibr4-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/head.13407"},{"key":"bibr5-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2002.0420s1003.x"},{"key":"bibr6-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06711-3"},{"key":"bibr7-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/head.12962"},{"key":"bibr8-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/head.13179"},{"key":"bibr9-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2000.tb11905.x"},{"key":"bibr10-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-013-0061-2"},{"key":"bibr11-03331024241259456","unstructured":"Valeant Pharmaceuticals North America LLC. Dihydroergotamine mesylate nasal spray prescribing information, https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020148Orig1s025lbl.pdf (2019, accessed 22 April 2024)."},{"key":"bibr12-03331024241259456","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1111\/head.14259","volume":"62","author":"Bertz R","year":"2022","journal-title":"Headache"},{"key":"bibr13-03331024241259456","first-page":"108","volume":"62","author":"Bertz R","year":"2022","journal-title":"Headache"},{"key":"bibr14-03331024241259456","first-page":"140","volume":"62","author":"Bhardwaj R","year":"2022","journal-title":"Headache"},{"key":"bibr15-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1111\/head.14389"},{"key":"bibr16-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(22)00517-8"},{"key":"bibr17-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"bibr18-03331024241259456","first-page":"26","volume":"6","author":"Coric V","year":"2009","journal-title":"Psychiatry (Edgmont)"},{"key":"bibr19-03331024241259456","unstructured":"National Cancer Institute. Common Technical Criteria for Adverse Events (CTCAE) Version 5.0, https:\/\/ctep.cancer.gov\/protocolDevelopment\/electronic_applications\/ctc.htm#ctc_50 (2017, accessed 22 April 2024)."},{"key":"bibr20-03331024241259456","unstructured":"Division of AIDS. National Institute of Allergy and Infectious Disease. Division of AIDS (DAIDS) Table\u00a0for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, https:\/\/rsc.niaid.nih.gov\/sites\/default\/files\/daidsgradingcorrectedv21.pdf (2017, accessed 22 April 2024)."},{"key":"bibr21-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000000771"},{"key":"bibr22-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1177\/0333102415584308"},{"key":"bibr23-03331024241259456","unstructured":"US Food and Drug Administration. Assessment of Abuse Potential of Drugs. Guidance for Industry, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/assessment-abuse-potential-drugs (2017, accessed 22 April 2024)."},{"key":"bibr24-03331024241259456","doi-asserted-by":"publisher","DOI":"10.1177\/00034894211007222"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024241259456","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024241259456","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024241259456","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:46:25Z","timestamp":1777387585000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03331024241259456"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":24,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1177\/03331024241259456"],"URL":"https:\/\/doi.org\/10.1177\/03331024241259456","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]},"article-number":"03331024241259456"}}