Safety of Diazepam Buccal Film in Children with Epilepsy: Subgroup Results from a Phase 3, Open-Label, Safety and Tolerability Study
Abstract number :
1.275
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1826709
Source :
www.aesnet.org
Presentation date :
12/4/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:56 AM
Authors :
Ayman Kafal, PhD - Aquestive Therapeutics; Carla Buan - Aquestive Therapeutics; Michael Gelfand - University of Pennsylvania; Allen Heller - Pharma Study Design, LLC; syndi Seinfeld - Joe DiMaggio Children’s Hospital; gary Slatko - Aquestive Therapeutics
Rationale: Epilepsy is one of the most common neurologic disorders seen in children, affecting one to two percent of children worldwide. Patients with severe and poorly controlled epilepsy are more likely to experience seizure clusters. It is estimated up to 14% of children continue to have seizures despite being treated with antiseizure medications. Use of rescue medications in acute management of seizure clusters can help avoid progression to status epilepticus and reduce emergency room visits.
Methods: This was a Phase 3, multicenter, open-label, long-term safety and tolerability study of chronic, intermittent use of Diazepam Buccal Film (DBF). The study population included children (2 to 12 years old), adolescents (13 to 16 years old), and adults (17 to 65 years old) with a clinical diagnosis of epilepsy and with bouts of increased seizure activity despite a stable antiepileptic regimen. Administration of DBF -5, 7.5, 10, 12.5, 15, or 17.5 mg was based on patient weight, with a second dose, if needed, 4 to 12 hours later. Safety was assessed.
Results: A sub-analysis of pediatrics data was performed. Of the 49 pediatric subjects enrolled in the study, 38 (77.6%) received at least 1 dose of DBF for a breakthrough seizure. 34 subjects (2-16 years old) completed the study, 38 patients were included in the Safety Analysis Set, and 283 use occasions were recorded in the electronic diary. Of these 283 use occasions, 24 (100%), 94 (100%), and 161 (98%) film insertions were successfully placed against the buccal mucosa in 2-5 years age group, 6-11 years age group, and 12-16 years age group, respectively. Additionally, it took only one attempt to insert the films in 24 (100%), 89 (95%), and 156 (95%) use occasion in the 2-5 years age group, 6-11 years age group, and 12-16 years age group, respectively.
Throughout this long-term study, 110 TEAEs were reported for 28/38 (74%) subjects. As expected in this population, the most frequently reported TEAE was seizure; 21 seizure events were reported for 9/38 (24%) subjects. In all age groups and all onset doses, most TEAEs were mild to moderate and transient. No patients discontinued because of any related adverse event.
Conclusions: In this sub-analysis of a long-term safety study, the safety profile of Diazepam Buccal Film was similar between all age groups.
Funding: Please list any funding that was received in support of this abstract.: Aquestive Therapeutics.
Anti-seizure Medications