Abstracts

Rationale: Rescue medications are given as needed in an attempt to disrupt the progression of a given seizure and forestall what would otherwise be a more prolonged or more severe clinical event. New treatments continue to evolve beyond simply treating seizures to address many additional factors that improve a patient’s health and increase their ability to use their medications more efficiently and adhere to their treatment regimen.

Methods: This was a Phase 3 multicenter, open-label, long-term study to assess the safety and tolerability of DBF administered a minimum of 3 times to subjects with epilepsy for the treatment of seizures over a minimum 6-month period.The study was conducted in male and female pediatric (2 to 11 years old), adolescent (12 to 16 years old), and adult subjects (17 to 65 years old) with a clinical diagnosis of epilepsy with bouts of increased seizure activity and who were on chronic intermittent use of rescue medication—the subjects in this study administered study drug themselves or with the help of a caregiver.

Results: Of the 150 subjects enrolled in the study, 130 (86.7%) received at least 1 dose of DBF for a breakthrough seizure and were included in the Safety Analysis Set, and 108 subjects (72%) completed the study. A total of 1348 use occasions were recorded in the electronic diary. Of these 1348 use occasions, 1268 (94%) film insertions were successfully placed against the buccal mucosa on the first attempt by the study subject or with the help of a parent/caregiver. For most of the remaining occasions, the film was placed successfully on a subsequent insertion attempt. Tracking DBF usability throughout the study demonstrated the potential for self-administration, and DBF can be successfully dosed throughout the seizure event life cycle. A total of 29 subjects (ages 14 to 62) self-administered at least 1 DBF dose over the course of the study. Overall, the total number of self-administered doses for the 29 subjects was 214 (mean 7.4; range 1 to 28 doses). DBF doses were administered throughout the seizure event life cycle (i.e., peri-ictal, ictal, and post-ictal). A total of 619 (47.7%) of the total 1297 first use occasions occurred from the time of seizure to 5 minutes after the seizure.

Throughout this long-term study, 382 TEAEs were reported for 84/130 (64.6%) subjects. As expected in this population, the most frequently reported TEAE was seizure; 98 seizure events were reported for 26/130 (20%) subjects. In all age groups and all onset doses, most TEAEs were mild to moderate and transient. Twenty-seven of the 382 TEAEs reported were severe and occurred in 14/130 (10.8%). Somnolence and fatigue were the most common treatment-related TEAEs overall.

Conclusions: These observations show DBF is a safe, well-tolerated, and usable treatment for chronic intermittent use as a rescue medication for patients with epilepsy (2 to 62 years of age).

Funding: Please list any funding that was received in support of this abstract.: Aquestive Therapeutics.