{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T10:53:43Z","timestamp":1762080823792,"version":"build-2065373602"},"reference-count":25,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,8,7]],"date-time":"2020-08-07T00:00:00Z","timestamp":1596758400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006506","name":"Depomed","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006506","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the pharmacokinetics, safety, and tolerability of a single 50\u2010mg oral dose of diclofenac potassium for oral solution (OS) in a pediatric cohort with a diagnosis of episodic migraine; the 3\u2010month safety trial following an outpatient dosing period was also evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Children and adolescents often experience migraine pain that is poorly controlled, which may affect their emotional and psychological well\u2010being. Diclofenac potassium for OS is approved for the treatment of migraine with aura (MWA) or migraine without aura (MWoA) in adults 18\u00a0years of age or older. It is formulated in a soluble buffered powder that provides more rapid absorption than the tablet formulations of diclofenac potassium. In a randomized, double\u2010blind, crossover trial, more adult patients were pain\u2010free at 2\u00a0hours post\u2010dose following treatment with diclofenac potassium for OS than those who received the diclofenac tablet formulation or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a Phase 4 open\u2010label study that took place at 2 US sites. Participants 12\u201017\u00a0years of age with a diagnosis of episodic MWA or MWoA for \u22653\u00a0months and \u226414 headaches per month were enrolled in the study. Participants received one 50\u2010mg dose of diclofenac potassium for OS under fasted conditions on day 1. Blood samples were collected for PK analysis within 15\u00a0minutes pre\u2010dose and at 5, 10, 15, 20, 30, 40, and 60\u00a0minutes post\u2010dose, and at 2, 4, and 6\u00a0hours post\u2010dose. Safety evaluations were performed after the initial dose and at the end of study on day 90; adverse events were monitored throughout the study. After completing the PK assessments, participants were given a 3\u2010month supply (27 packets) of diclofenac potassium for OS (50\u2010mg doses) for their migraine attacks. Participants were advised to take diclofenac potassium for OS at the onset of a migraine. They were told to take no more than 2 doses daily and not to use it more than 3\u00a0days\/week.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty\u2010five participants completed the study; 84% were females and 96% were white or Caucasian, with a mean age of 15.5\u00a0years and a mean weight of 63.1\u00a0kg. Diclofenac was rapidly absorbed with a median time to maximum concentration of 15\u00a0minutes and a mean peak plasma concentration of 1412 (\u00b1846.2) ng\/mL. Diclofenac had a half\u2010life of 66.8 (\u00b19.2) minutes. The mean area under the concentration\u2010time curve from zero to the last measurable time point was 82,920.0 (\u00b125,327.6) minutes\u00a0\u00d7\u00a0ng\/mL, and the mean area under the concentration\u2010time curve from time zero to infinity was 84,388.8 (\u00b125,993.6) minutes\u00a0\u00d7\u00a0ng\/mL. Participants took the study drug an average of 10 times over 79\u00a0days, with an overall total drug exposure of 506\u00a0mg. No deaths or discontinuations due to an AE were reported during the study. The most frequently reported treatment emergent adverse events were arthralgia and motion sickness, each of which occurred in 2 (8%) of the participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Diclofenac potassium for OS exhibited a favorable pharmacokinetic and safety profile in 12\u2010 to 17\u2010year\u2010old patients with a diagnosis of episodic MWA or MWoA.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.13922","type":"journal-article","created":{"date-parts":[[2020,8,8]],"date-time":"2020-08-08T01:40:56Z","timestamp":1596850856000},"page":"1939-1946","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["An Open\u2010Label Study Evaluating the Pharmacokinetics and Safety of Diclofenac Potassium for Oral Solution for the Acute Treatment of MWA or MWoA in Pediatric 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M.","family":"Ferger","sequence":"additional","affiliation":[{"name":"Department of Administration Dent Neurologic Institute Amherst NY 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