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Abstract Details

Crossover Study Evaluating the Effect of Seizures on the Absorption of Diazepam from a Buccal Film Formulation in Children with Epilepsy
Epilepsy/Clinical Neurophysiology (EEG)
P9 - Poster Session 9 (8:00 AM-9:00 AM)
1-006

Diazepam buccal film (DBF) is a novel diazepam dosage form for treating acute repetitive seizures. This study compares diazepam exposures obtained when DBF is administered to children in either the periictal state (during a seizure or less than 5 min from seizure cessation) or interictal state (between seizures).

To compare plasma exposures from diazepam buccal film (DBF) administered in children with epilepsy under periictal or interictal conditions.

Male and female children ages 2-16 years old with refractory epilepsy received DBF at doses of 5.0 to 17.5 mg in an epilepsy monitoring unit setting. Blood was collected over 4 hours for analysis of diazepam plasma concentrations. Pharmacokinetic parameters were determined by noncompartmental analysis.

Twenty-four patients received at least one dose of study drug; 17 in the interictal period and 16 in the periictal period, with 9 subjects dosed in both periods. Diazepam least square mean maximum plasma concentrations were somewhat higher in the interictal state than in the periictal state, but these differences were not statistically significant. There was no difference in the median time to maximum diazepam concentration when patients were dosed in either seizure state.

Even if DBF is administered in close proximity to a seizure, the maximum plasm diazepam concentration achieved is comparable to that observed when DBF is dosed in between seizures. Likewise, the speed of diazepam absorption is not affected by dosing DBF either during or between seizures. DBF provides a convenient way to deliver diazepam for the treatment of acute repetitive seizure emergencies in children.

Authors/Disclosures
Stephen Wargacki
PRESENTER
No disclosure on file
Stephanie M. Varjan (Aquestive Therapeutics, Inc.)
PRESENTER
No disclosure on file
Gary Slatko, MD (Aquestive Therapeutics) Dr. Slatko has received personal compensation for serving as an employee of Aquestive Therapeutics. Dr. Slatko has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aquestive Therapeutics.
Michael A. Rogawski, MD, PhD (University of California - Davis) Dr. Rogawski has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Xenon Pharmaceuticals.