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Abstract Details

An Open-Label Study Evaluating the Pharmacokinetics and Safety of Diclofenac Potassium for Oral Solution for the Acute Treatment of Migraine With or Without Aura in Pediatric Participants
Headache
Headache Posters (7:00 AM-5:00 PM)
100

Diclofenac potassium for OS is approved for treatment of migraine with/without aura in adults, formulated in a soluble powder providing rapid absorption. In a randomized, double-blind, crossover trial, more adult patients were pain-free at 2 hours post-dose following treatment with diclofenac potassium for OS than those who received the diclofenac tablet or placebo.


Evaluate the pharmacokinetics, safety, and tolerability of a 50-mg oral dose of diclofenac potassium for oral solution (OS) in a pediatric cohort with diagnosis of episodic migraine.
 Participants 12  to 17 years (n=25) with a diagnosis of episodic migraine with/without aura (3-14 headaches/month) were enrolled. Participants received 50-mg  of diclofenac potassium for OS after fasting on day 1. Blood samples were collected for PK analysis within 15 minutes pre-dose and at 5, 10, 15, 20, 30, 40, and 60 minutes, as well as 2, 4, and 6 hours post-dose. After, participants were given a 3-month supply to take at the onset of a migraine attack.
The medicine was rapidly absorbed with a median time to maximum concentration of 15 minutes and a mean peak plasma concentration of 1412 (+/- 846.2)ng/mL. The mean area under the concentration-time curve from zero to the last measurable time point was 82,920.0 (+/-25,327.6)min*ng/mL, and the mean area under the concentration-time curve from time zero to infinity was 84,388.8 (+/-25,993.6)min*ng/mL. Participants took the study drug an average of 10 times over 79 days. Adverse events of arthralgia and motion sickness were each reported (n=2), no patients discontinued due to adverse events.
Diclofenac potassium for OS exhibited a favorable pharmacokinetic and safety profile in 12–17 year old patients with a diagnosis of episodic migraine with/without aura.
Authors/Disclosures
Jennifer W. McVige, MD (Dent Neurological Institute)
PRESENTER
Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/AbbVie. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. McVige has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. McVige has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurelis. The institution of Dr. McVige has received research support from Amgen. The institution of Dr. McVige has received research support from Eli Lily. The institution of Dr. McVige has received research support from Biohaven. The institution of Dr. McVige has received research support from Lundbeck. The institution of Dr. McVige has received research support from Dent Family Foundation. Dr. McVige has a non-compensated relationship as a Neurology Board with UCNS that is relevant to AAN interests or activities. Dr. McVige has a non-compensated relationship as a Board Exam Board Member with ABPN that is relevant to AAN interests or activities.
Rebecca Hogan (Dent Neurologic Institute) Rebecca Hogan has nothing to disclose.
Clayton Shanahan Mr. Shanahan has nothing to disclose.
Diane L. Amend, PhD (Bayhill Therapeutics) No disclosure on file
Shawn Michael Ferger, RN (Dent Neurologic Institute) Mr. Ferger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia Pharmaceuticals. Mr. Ferger has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan Pharmaceuticals.
Megan Rooney Megan Rooney has nothing to disclose.