{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:20:16Z","timestamp":1787664016885,"version":"build-2736575974"},"reference-count":30,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T00:00:00Z","timestamp":1785369600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T00:00:00Z","timestamp":1785369600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Dihydroergotamine (DHE) prescribing information contains a boxed warning regarding the possibility of serious and\/or life\u2010threatening peripheral ischemia with co\u2010administration of strong cytochrome P450 3A4 (CYP3A4) inhibitors. The effects of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics and safety of nasally administered STS101 (DHE) were evaluated in this open\u2010label, 2\u2010period, fixed sequence study in 31 healthy participants. Following a single dose of 5.2 mg STS101, DHE exposure when co\u2010administered with itraconazole was 119% and 114% of that when administered alone, for the area under the plasma concentration\u2013time curve from time 0 to infinity (AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    ), and maximum observed plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ), respectively. Co\u2010administration of STS101 with itraconazole was not associated with an increase in the frequency of treatment emergent adverse events compared with STS101 alone. No clinically significant findings of a single dose of 5.2 mg STS101 alone or with itraconazole were observed on nasal examinations, safety laboratory values, vital signs, or safety electrocardiograms. In this study, no clinically meaningful drug\u2013drug interactions were seen when STS101 was co\u2010administered with a strong CYP3A4 inhibiting drug.\n                  <\/jats:p>","DOI":"10.1002\/jcph.70239","type":"journal-article","created":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T12:16:12Z","timestamp":1785413772000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["An Open\u2010Label, 2\u2010Period, Fixed Sequence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of STS101 (Dihydroergotamine Nasal Powder), with and without Concomitant Itraconazole in Healthy Adult Subjects"],"prefix":"10.1002","volume":"66","author":[{"given":"Detlef","family":"Albrecht","sequence":"first","affiliation":[{"name":"Satsuma Pharmaceuticals Inc.  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Hussey","sequence":"additional","affiliation":[{"name":"Allucent  Cary NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.","family":"Lipton","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine and Montefiore Headache Center  Bronx NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2003.03034.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12499"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2011.01869.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0196-0644(98)70126-X"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2001.01191.x"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.1996.00550120097022"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.36.7.995"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.1996.00550020092020"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.45.3.577"},{"issue":"1","key":"e_1_2_8_11_1","first-page":"S33","article-title":"Ergotamine tartrate and dihydroergotamine mesylate: safety profiles","volume":"37","author":"Lipton RB","year":"1997","journal-title":"Headache"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102414544977"},{"key":"e_1_2_8_13_1","unstructured":"D.H.E.45\u00ae Prescribing Information.Bridgewater (NJ):Valeant Pharmaceuticals;2019."},{"key":"e_1_2_8_14_1","unstructured":"Trudhesa\u2122Prescribing Information.(dihydroergotamine mesylate) nasal spray. Impel NeuroPharma Inc.Milano (IT):Mipharm S.p.A.;2019."},{"key":"e_1_2_8_15_1","unstructured":"Migranal\u00aePrescribing Information.Aliso Viejo (CA):Valeant Pharmaceuticals;2019."},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102411432299"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1472-8206.1991.tb00700.x"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF03188756"},{"key":"e_1_2_8_19_1","unstructured":"ATZUMI\u2122 Prescribing Information 2025; Satsuma Pharmaceuticals; satsumarx.com"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14685"},{"key":"e_1_2_8_21_1","unstructured":"Itraconazole Capsules Prescribing Information 2020; Northstar Rx LLC"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.562"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2006.00605.x"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2010.01662.x"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2013.787980"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1086\/598327"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2009.01510.x"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.3389\/fgene.2019.00224"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.comtox.2019.100092"},{"key":"e_1_2_8_30_1","unstructured":"AlbrechtD StromS.DHE plasma concentration and clinical response relationship: an in\u2010office PK\u2010PD study [Poster P\u2010305]. 67th Annual Scientific Meeting of the American Headache Society; 2025 Jun 19\u201322; Minneapolis (MN)."},{"key":"e_1_2_8_31_1","unstructured":"US Food and Drug Administration Guidance for Industry: M12 Drug Interaction Studies 2024;https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/m12\u2010drug\u2010interaction\u2010studies"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.70239","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.70239","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.70239","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T12:33:31Z","timestamp":1787661211000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.70239"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,30]]},"references-count":30,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1002\/jcph.70239"],"URL":"https:\/\/doi.org\/10.1002\/jcph.70239","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,30]]},"assertion":[{"value":"2025-12-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70239"}}