{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:32:36Z","timestamp":1791977556365,"version":"4.4.0"},"reference-count":41,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T00:00:00Z","timestamp":1747699200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the safety and tolerability of zavegepant (ZAV) when used as needed for acute treatment of migraine in patients taking concomitant preventive migraine medications (anti\u2010calcitonin gene\u2010related peptide monoclonal antibodies [CGRP mAbs] or other select preventive migraine medications [OSPs]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>People with migraine often use preventive and acute treatments concomitantly for breakthrough attacks. ZAV 10\u2010mg nasal spray is the first intranasal, small\u2010molecule CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a subgroup analysis of data from a multicenter, single\u2010arm, open\u2010label, phase 2\/3 clinical trial that assessed the safety and tolerability of ZAV for the acute treatment of migraine. Participants self\u2010administered 1\u2009ZAV dose\/day as needed up to 8\u2009times\/month for up to 52\u2009weeks to treat migraine attacks of any severity. Participants were categorized into five cohorts based on their current or concomitant use of preventive treatments: ZAV\u2009+\u2009CGRP mAbs, ZAV\u2009+\u2009OSPs, ZAV\u2009+\u2009CGRP mAbs or OSPs, ZAV monotherapy (ZAVmono), and the overall study population. Adverse events (AEs), clinical laboratory results, and vital signs data were evaluated and summarized descriptively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 603 participants self\u2010administered \u22651 dose of ZAV and 341 participants (56.6%) completed the study. Among the 603 ZAV\u2010treated participants, 39 (6.5%) received ZAV\u2009+\u2009CGRP mAbs, 72 (11.9%) received ZAV\u2009+\u2009OSPs, 103 (17.1%) received ZAV\u2009+\u2009CGRP mAbs or OSPs (eight participants received both CGRP mAbs and OSPs), and 500 (82.9%) received ZAVmono. Baseline characteristics were similar across cohorts. The mean number of ZAV doses self\u2010administered per month was similar across cohorts (3.1\u20133.3). The proportion of participants experiencing an AE was similar across cohorts (range: 73.6\u201376.9%). The most frequent AEs were dysgeusia (range across cohorts: 28.2\u201341.7%), nasal discomfort (9.7\u201315.4%), COVID\u201019 (7.2\u20138.7%), nausea (4.2\u201310.3%), back pain (4.4\u201315.4%), throat irritation (4.4\u201312.8%), and nasal congestion (5.2\u20137.7%). Most AEs had mild\u2010to\u2010moderate severity and resolved without treatment. The proportion of participants who discontinued due to an AE was similar across cohorts (range: 4.2\u20137.7%). No serious AEs related to ZAV treatment occurred. The proportion of participants who experienced a local\u2010irritation AE was similar across cohorts (range: 49.4\u201351.4%), as was the proportion who experienced a hepatic\u2010related AE (3.8\u20137.7%). No AEs related to medication\u2010overuse headache, suicidality, or cardiovascular events occurred. No clinically meaningful trends in laboratory test results or vital signs were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Self\u2010administration of ZAV 10\u2010mg nasal spray for the acute treatment of migraine up to 8\u2009times\/month for up to 52\u2009weeks appeared well\u2010tolerated irrespective of concomitant use of CGRP mAbs or OSPs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14954","type":"journal-article","created":{"date-parts":[[2025,5,20]],"date-time":"2025-05-20T07:23:33Z","timestamp":1747725813000},"page":"1180-1189","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Long\u2010term safety and tolerability of zavegepant 10\u2010mg nasal spray with concomitant use of anti\u2010calcitonin gene\u2010related peptide monoclonal antibodies or other select 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