{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T20:10:02Z","timestamp":1788466202583,"version":"build-2803163510"},"reference-count":33,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T00:00:00Z","timestamp":1761264000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T00:00:00Z","timestamp":1761264000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate pharmacokinetics (PK), safety, and tolerability of a weight\u2010adjusted dose of rimegepant orally disintegrating tablet (ODT) in children (aged \u22656 to &lt;12\u2009years) with a history of migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Rimegepant 75\u2009mg ODT is approved for acute treatment of migraine (with or without aura) and preventive treatment of episodic migraine in adults. Studies of rimegepant in pediatric populations have not been conducted to date.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this phase 1 open\u2010label study, a single dose of rimegepant ODT was administered, based on body weight, to children aged \u22656 to &lt;12\u2009years. Children with body weight\u2009\u226515\u2009kg to \u226430\u2009kg received 25\u2009mg (group 1;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20097), children &gt;30\u2009kg to \u226450\u2009kg received 50\u2009mg (2\u2009\u00d7\u200925\u2009mg; group 2;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20099), and children &gt;50\u2009kg received 75\u2009mg (group 3;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095). Blood samples were collected pre\u2010dose and 0.5, 1.25, 3.5, and 18\u2009h post\u2010dose and then analyzed using a validated bioanalytical assay. Rimegepant PK parameters, including area under the plasma concentration\u2013time curve (AUC) from time zero to infinity (AUC\n                      <jats:sub>inf<\/jats:sub>\n                      ), AUC from time zero to 24\u2009h after dosing, maximum plasma concentration (\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      ), and time to\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      were estimated using a population PK approach in which pediatric PK data from this study were used to update a previous rimegepant population PK model developed with adult data. A safety follow\u2010up phone call was conducted 4\u2009days after dosing.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Twenty participants with \u22651 post\u2010dose PK sample were included in PK analyses. All 21 participants treated were analyzed for safety. A majority of the study population was White (67%) and female (57%), had a median (range) age of 9.0 (6 to 11) years, and a mean (standard deviation) body weight of 37.7 (12.3) kg. Geometric mean estimates of\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      and AUC\n                      <jats:sub>inf<\/jats:sub>\n                      ranged from 615.9 to 811.1\u2009ng\/mL and 1987.8 to 4244.9\u2009ng*h\/mL, respectively, across weight groups. Rimegepant exposures, particularly AUC\n                      <jats:sub>inf<\/jats:sub>\n                      values, were lower in the two lower\u2010weight groups (groups 1 and 2) than in the higher\u2010weight group (group 3). Median time to\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      was 1 to 1.5\u2009h across weight\/dose groups. Three (14%) participants (all in group 3) had \u22651 adverse event; all were mild in severity. No clinically relevant findings regarding laboratory tests, vital signs, electrocardiograms, physical examinations, local tolerability assessments, or the Sheehan\u2010Suicidality Tracking Scale were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A single weight\u2010adjusted dose of rimegepant ODT demonstrated a favorable safety profile in children aged \u22656 to &lt;12\u2009years with a history of migraine. Exposures in children &gt;50\u2009kg receiving 75\u2009mg rimegepant were similar to observed exposures in adults receiving 75\u2009mg. However, exposures in children &gt;30\u2009kg to \u226450\u2009kg receiving 50\u2009mg rimegepant and in children \u226515\u2009kg to \u226430\u2009kg receiving 25\u2009mg rimegepant were lower than exposures in adults receiving 75\u2009mg. These findings will be the basis for further refinement of pediatric dose in future studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.15074","type":"journal-article","created":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T10:29:54Z","timestamp":1761301794000},"page":"202-212","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A phase 1, multicenter, open\u2010label study to evaluate the pharmacokinetics, safety, and tolerability of a single dose of rimegepant in children (aged \u22656 to &lt;12\u2009years) with a history of migraine"],"prefix":"10.1111","volume":"66","author":[{"given":"Chay Ngee","family":"Lim","sequence":"first","affiliation":[{"name":"Pfizer Inc.  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