{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:32:35Z","timestamp":1791977555400,"version":"4.4.0"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T00:00:00Z","timestamp":1767830400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T00:00:00Z","timestamp":1767830400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study evaluated the pharmacokinetics of zavegepant in human breast milk and plasma following a single, 10\u2009mg dose of zavegepant nasal spray.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Zavegepant nasal spray is a member of the gepant class of medications; small molecule inhibitors of the calcitonin gene\u2010related peptide receptor. It is approved in the United States for the acute treatment of migraine with or without aura in adults. However, the transfer of zavegepant to human breast milk in lactating women has not been assessed previously.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this Phase 1, open\u2010label, single\u2010arm, single\u2010dose, pharmacokinetic study (NCT06453356), 12 healthy lactating women received a single intranasal dose of 10\u2009mg zavegepant. Blood and breast milk samples were collected over 24\u2009h postdose to assess zavegepant pharmacokinetics. Safety was also assessed. The study was conducted from June 10 to September 26, 2024 at a single\u2010site in the United States.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Geometric mean (geometric percent coefficient of variation [CV%]) milk\u2010to\u2010plasma zavegepant concentration ratios were 0.21 (102%), 0.16 (76%), and 0.04 (130%) for area under the concentration\u2013time curve from time 0 to 24\u2009h postdose, area under the concentration\u2013time curve from time 0 extrapolated to infinity, and maximum concentration, respectively. The geometric mean (geometric CV%) body weight normalized infant dose was 0.05\u2009\u03bcg\/kg\/day (120%) and the geometric mean (geometric CV%) body weight normalized maternal dose was 132.8\u2009\u03bcg\/kg\/day (10%). This resulted in a geometric mean (geometric CV%) relative infant dose of 0.04% (128%). One treatment\u2010emergent adverse event (TEAE; mild dizziness) was reported in one (8%) participant. This TEAE was considered mild in severity. No clinically meaningful abnormalities were observed for vital signs, clinical laboratory testing, and local nasal assessments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>A single intranasal dose of 10\u2009mg zavegepant was generally safe and well tolerated in healthy lactating women and the estimated infant exposure to zavegepant via breast milk is very low.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.70036","type":"journal-article","created":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T08:35:57Z","timestamp":1767861357000},"page":"1050-1057","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10\u2009mg intranasal dose in healthy lactating women"],"prefix":"10.1111","volume":"66","author":[{"given":"Abhijeet","family":"Jakate","sequence":"first","affiliation":[{"name":"Pfizer Inc.  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Weng","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ani","family":"Shkrodova","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ogert","family":"Fisniku","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Lake Forest Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ding","family":"Ding","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayce","family":"Morton","sequence":"additional","affiliation":[{"name":"Phoenix Children's Hospital  Phoenix Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Maligalig","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Makati Philippines"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Garnick","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9481-5961","authenticated-orcid":false,"given":"Jing","family":"Liu","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed H.","family":"Shahin","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,8]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-020-01208-0"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39559.675891.AD"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2003.00480.x"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14153"},{"key":"e_1_2_13_6_1","doi-asserted-by":"crossref","DOI":"10.1177\/03331024241252666","article-title":"International Headache society global practice recommendations for the acute pharmacological treatment of migraine","volume":"44","author":"Puledda F","year":"2024","journal-title":"Cephalalgia"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/brainsci12121612"},{"key":"e_1_2_13_8_1","unstructured":"Pfizer.Zavagepant prescribing information.2025."},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.70015"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.70048"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1089\/bfm.2021.0250"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14960"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-025-00772-4"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12064"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-026690"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/aogs.13570"},{"key":"e_1_2_13_17_1","unstructured":"US Food and Drug Administration clinical lactation studies: considerations for study design guidance for industry [Draft Guidance].2019."},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14853"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13813"},{"key":"e_1_2_13_20_1","first-page":"1","article-title":"Comparative bioavailability of single\u2010dose zavegepant during and between migraine attacks: A phase 1, randomized, open\u2010label, fixed\u2010sequence, two\u2010period study","volume":"00","author":"Bertz RJ","year":"2024","journal-title":"Headache"},{"key":"e_1_2_13_21_1","doi-asserted-by":"crossref","DOI":"10.1177\/1745506520957192","article-title":"A single\u2010arm study to evaluate the transfer of drospirenone to breast milk after reaching steady state, following oral administration of 4\u2009mg drospirenone in healthy lactating female volunteers","volume":"16","author":"Melka D","year":"2020","journal-title":"Womens Health (Lond)"},{"key":"e_1_2_13_22_1","volume-title":"Drugs and human lactation: a comprehensive guide to the content and consequences of drugs, micronutrients, radiopharmaceuticals, and environmental and occupational chemicals in human milk","author":"Bennett PN","year":"1996"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.70036","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.70036","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.70036","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T14:42:44Z","timestamp":1786632164000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.70036"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1,8]]},"references-count":21,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["10.1111\/head.70036"],"URL":"https:\/\/doi.org\/10.1111\/head.70036","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1,8]]},"assertion":[{"value":"2025-04-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}