Adjunctive Eslicarbazepine Safe and Well Tolerated for Pediatric Seizures
The US Food and Drug Administration has approved the use of eslicarbazepine for the treatment of pediatric partial-onset seizures in children ≥4 years of age.
|The following article is part of conference coverage from the 2018 American Academy of Neurology Annual Meeting in Los Angeles, California. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2018.|
LOS ANGELES — Adjunctive eslicarbazepine was found to be generally well tolerated in pediatric patients aged 4 to 17 years with partial-onset (focal) seizures, with a pediatric safety profile analogous to that found in adult patients, according to research presented at the 70th annual American Academy of Neurology meeting, held April 21-27, 2018, in Los Angeles, California.
Once-daily oral eslicarbazepine is approved by the US Food and Drug Administration for the treatment of partial-onset seizures in patients ≥4 years of age. The study investigators conducted post-hoc analysis of pooled data from 2 double-blind, randomized, placebo-controlled trials to evaluate the tolerability and safety of adjunctive eslicarbazepine in this patient population. The drug had been previously found to be well tolerated and safe for adults with partial-onset seizures.
In the first of the 2 studies analyzed, 305-Part 1, pediatric patients (2 to 17 years) received 18 weeks of eslicarbazepine at a target dosage of 20 mg/kg/d. In the second study, 208-Part 1, pediatric patients (6 to 16 years) received 12 weeks of eslicarbazepine at a target dosage of 30 mg/kg/d. The researchers evaluated serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and TEAEs leading to study discontinuation.
The incidence of TEAEs associated with eslicarbazepine and placebo was similar (67.8% vs 65.6%), with diplopia, headache, somnolence, and vomiting being reported most frequently in participants receiving eslicarbazepine (6.4% to 13.9%). The incidence of other individual TEAEs was ≤5%. Cluster seizures caused one death in the eslicarbazepine group. Discontinuation due to SAEs and TEAEs was more common among participants receiving eslicarbazepine (9.9% and 5.9%, respectively) compared with placebo (5.0% and 2.5%).
The incidence of allergic reactions was increased with eslicarbazepine than placebo (5.0% vs 1.3%), and one patient taking eslicarbazepine experienced DRESS [drug reaction with eosinophilia and systemic symptoms) syndrome (0.5%). Hypothyroidism was infrequent (1.0% eslicarbazepine vs 0.6% placebo), and one patient receiving eslicarbazepine had a post-dose plasma sodium measurement ≤125mEq/L.
The study investigators determined that overall, eslicarbazepine was generally well tolerated in pediatric patients with partial-onset seizures, and the pediatric safety profile of the drug was comparable to that reported in adult patients.
The study was supported by BIAL and Sunovion Pharmaceuticals Inc.
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Mintz M, Pina-Garza J, Wolf S, et al. Safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4–17 years) with partial-onset (focal) seizures (POS). Poster presented at: 2018 AAN Annual Meeting; April 21-27, 2018; Los Angeles, CA. Poster 269.