Safety and Tolerability of Adjunctive Eslicarbazepine Acetate (ESL) in Pediatric Patients (Aged 4–17 Years) with Partial-Onset (Focal) Seizures (POS) (P5.269)

Objective: To determine the safety and tolerability of adjunctive ESL for POS in pediatric patients. Background: The prevalence of epilepsy is high in childhood. ESL is a once-daily oral antiepileptic drug (AED) approved for use in patients ≥4 years of age with POS. Adjunctive ESL was previously found to be safe and well tolerated in adults (≥18 years) with POS. Design/Methods: This post-hoc analysis evaluated safety and tolerability data pooled from two randomized, double-blind, placebo-controlled trials (2093-208 and -305) of adjunctive ESL in pediatric patients (4–17 years) with POS refractory to treatment with 1–2 AEDs. In study 208-Part 1, patients (6–16 years) received ESL (target dose, 30mg/kg/day) for 12 weeks. In study 305-Part 1, patients (2–17 years) received ESL (target dose 20mg/kg/day) for 18 weeks. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation were evaluated. Results: The safety population (aged 4–17 years, ≥1 dose of study drug) was as follows: ESL, n=202 (mean dose [SD], 757.7[261.48]mg/day); placebo, n=160. TEAE incidence was similar between ESL (67.8%) and placebo (65.6%). Headache, somnolence, vomiting, and diplopia were most frequent in the ESL group (6.4–13.9%); the incidence of all other individual TEAEs was ≤5%. SAEs and TEAEs leading to discontinuation were more common with ESL (9.9% and 5.9%, respectively) than placebo (5.0% and 2.5%). One death occurred in the ESL group, due to cluster seizures. Allergic reaction TEAE incidence was numerically higher with ESL (5.0%) versus placebo (1.3%). DRESS syndrome was reported in one patient receiving ESL (0.5%). Hypothyroidism was infrequent (ESL, 1.0%; placebo, 0.6%). One patient taking ESL had a post-dose plasma sodium measurement ≤125mEq/L. Conclusions: ESL was generally well tolerated in pediatric patients (4–17 years) with POS. The pediatric safety profile of ESL was comparable to that reported in adults. Study Supported by: BIAL and Sunovion Pharmaceuticals Inc. Disclosure: Dr. Mintz has received personal compensation in an editorial capacity for Journal of Child Neurology; Vision Development and Rehabilitation. Dr. Pina-Garza has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion, UCB Pharma, Supernus, Lundbeck, Eisai. Dr. Wolf has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion, Lundbeck, Eisai, Supernus, GLG. Dr. McGoldrick has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai, Lundbeck, Supernus, Sunovion, GW, Neuropace. Dr. Grinnell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Cantu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Costa has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with BIAL — Portela & Ca., S.A. Dr. Moreira has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with BIAL — Portela & Ca., S.A. Dr. Li has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sunovion Pharmaceuticals Inc. Dr. Jozwiak has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis. Dr. Blum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc.