{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T23:17:53Z","timestamp":1790637473273,"version":"4.1.0"},"reference-count":17,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,6,23]],"date-time":"2020-06-23T00:00:00Z","timestamp":1592870400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007819","name":"Allergan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007819","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Calcitonin gene\u2013related peptide is a potent vasodilatory neurotransmitter believed to play a key role in the pathophysiology of migraine. Ubrogepant (UBRELVY\u2122) is a potent and selective antagonist of the human calcitonin gene\u2013related peptide receptor approved for the acute treatment of migraine. Sumatriptan is a serotonin receptor agonist and the most commonly used triptan for the acute treatment of migraine. Ubrogepant could be prescribed with triptans.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>The Phase 1 study was a single\u2010center, open\u2010label, randomized, 3\u2010way crossover, single\u2010dose, pharmacokinetic interaction study, where participants received each of 3 oral treatments with a 7\u2010day washout period between treatments: single dose of ubrogepant 100\u00a0mg, single dose of sumatriptan 100\u00a0mg, and ubrogepant 100\u00a0mg plus sumatriptan 100\u00a0mg. Pharmacokinetic parameters were calculated using a model\u2010independent approach. The ACHIEVE I and II trials were 2 multicenter, single\u2010attack, randomized, Phase 3 trials in adults with a history of migraine with or without aura. Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48\u00a0hours after the initial dose of study medication. Rescue medication options included acetaminophen, nonsteroidal anti\u2010inflammatory drugs, opioids, anti\u2010emetics, or triptans. Treatment\u2010emergent adverse events were evaluated up to 30\u00a0days after the last dose in the Phase 1 and Phase 3 studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Ubrogepant median time to maximum plasma concentration was delayed (3\u00a0hours [range: 1\u20105\u00a0hours] vs 1.5\u00a0hours [range: 1\u20104\u00a0hours]), mean maximum plasma concentration was reduced by 24% (coefficient of variation: 37.4%) when ubrogepant was coadministered with sumatriptan (n\u00a0=\u00a029) compared with ubrogepant administered alone (N\u00a0=\u00a030). No significant effect was observed on the area under the plasma concentration\u2010time curve of ubrogepant. Sumatriptan area under the curve and maximum plasma concentration showed no significant change when sumatriptan was coadministered with ubrogepant (n\u00a0=\u00a029), but the sumatriptan time to maximum plasma concentration was delayed (1\u00a0hour [range: 0.5\u20105\u00a0hours] vs 3\u00a0hours [range: 0.5\u20106\u00a0hours]. No treatment\u2010emergent adverse events were reported with the coadministration of ubrogepant 100\u00a0mg and sumatriptan 100\u00a0mg in the Phase 1 study. The pooled safety data from ACHIEVE trials (N\u00a0=\u00a01938) showed similar rates of treatment\u2010related treatment\u2010emergent adverse events between participants who took ubrogepant alone and participants who took ubrogepant and a triptan as a rescue medication (14.9% [53\/355] vs 12.8% [5\/39] in the ubrogepant 100\u00a0mg treatment group, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although there were slight alterations in ubrogepant pharmacokinetic parameters when coadministered with sumatriptan, such changes are expected to have minimal clinical relevance, especially because no changes were seen in sumatriptan area under the curve and maximum plasma concentration when coadministered with ubrogepant. Coadministration of ubrogepant with sumatriptan was well tolerated in healthy participants in the Phase 1 study, and coadministration of ubrogepant with triptans was well tolerated in participants with migraine in the Phase 3 trials. No new safety concerns for ubrogepant were identified across all trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.13862","type":"journal-article","created":{"date-parts":[[2020,6,23]],"date-time":"2020-06-23T07:48:04Z","timestamp":1592898484000},"page":"1340-1350","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans"],"prefix":"10.1111","volume":"60","author":[{"given":"Abhijeet","family":"Jakate","sequence":"first","affiliation":[{"name":"Allergan plc Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Boinpally","sequence":"additional","affiliation":[{"name":"Allergan plc Madison NJ 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