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Abstract Details

Safety and Tolerability Associated With Chronic Intermittent Use of Diazepam Buccal Film in Pediatric, Adolescent, and Adult Patients With Epilepsy
Epilepsy/Clinical Neurophysiology (EEG)
S31 - Epilepsy/Clinical Neurophysiology (EEG) 3 (5:06 PM-5:18 PM)
009
To assess the safety and tolerability of self- or caregiver-administered diazepam buccal film (DBF) in people with epilepsy (interim data; patients receiving ≥1 dose as of May 2019).
Seizure clusters occur in many patients with epilepsy despite treatment with antiepilepsy medications. DBF is a novel formulation of diazepam designed for easy administration, with a pharmacokinetic profile comparable to rectal diazepam.

Patients aged 2–65 years needing rescue benzodiazepines ≥1x/month were included. DBF (5–17.5 mg based on age and body weight) was administered by patients or caregivers in the home as needed (≤5 seizure episodes/month). Adverse events (AEs) and DBF usability assessed by patients/caregivers were collected after the first dose and every 3 months thereafter (NCT03428360).

 A total of 72 patients were included (adults, n=59; adolescents, n=7; pediatric, n=6). Five (6.9%) patients reported 7 treatment-related AEs over a mean (SD) of 192 (97) days of follow-up; all were mild and none led to discontinuation. Local buccal discomfort (mild) was reported in 1 patient. Thirteen serious AEs were reported, none of which were considered treatment-related. DBF usability data were reported by 64 (88.9%) patients, representing 471 DBF use occasions (mean [SD] 7.4 [7.7] administrations/patient). DBF was successfully administered during a first attempt on 443 of 471 (94.1%) use occasions and during a second attempt on 17 (3.6%) use occasions. All 64 patients had DBF administration first-attempt success on ≥1 use occasion. Patients and caregivers reported no difficulty opening the outer or inner packaging in the majority of use occasions and almost all reported no difficulty removing DBF from the inner packaging. 

DBF was safe and well tolerated by pediatric, adolescent, and adult patients with epilepsy experiencing seizure emergencies. DBF was ultimately successfully placed on 99.6% (469/471) of use occasions and readily used without difficulty.
Authors/Disclosures
Syndi Seinfeld, DO, FAAN (Joe DiMaggio Children's Hospital)
PRESENTER 		No disclosure on file
Michael Gelfand, MD, PhD (University of Pennsylvania) Dr. Gelfand has received personal compensation in the range of $0-$499 for serving as a Consultant for Aquestive. Dr. Gelfand has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Livanova. The institution of Dr. Gelfand has received research support from Aquestive. The institution of Dr. Gelfand has received research support from Xenon. The institution of Dr. Gelfand has received research support from Cerevel. The institution of Dr. Gelfand has received research support from UNEEG. The institution of Dr. Gelfand has received research support from Livanova. The institution of Dr. Gelfand has received research support from UCB. The institution of Dr. Gelfand has received research support from SK Pharma. The institution of Dr. Gelfand has received research support from Otsuka.
Allen H H. Heller, MD, MPH (Pharma Study Design LLC) Dr. Heller has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for Epalex Corporation. Dr. Heller has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Aquestive Therapeutics Inc.. Dr. Heller has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celanese Corporation. Dr. Heller has stock in Epalex Corporation.
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.