Eslicarbazepine Acetate Examined in Children With Partial-Onset Seizures

The NDA submission includes results from a clinical trial program that included over 1900 patients.
ESL is not currently FDA-approved for use in pediatric patients.

According to results of an analysis presented at the AES Annual Meeting, eslicarbazepine acetate (ESL) is well tolerated in pediatric patients for the treatment of partial-onset (focal) seizures (POS).

The analysis aimed to determine the safety and tolerability of adjunctive ESL in 4- to 17-year-old patients with POS that was refractory to 1–2 anti-epileptic drugs (AEDs). Safety data from a Phase 2 and a Phase 3 trial were pooled. Both trials were randomized, double-blinded, and placebo-controlled and had ESL target doses of 20mg/kg/day and 30mg/kg/day. The prevalence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), as well as TEAEs causing discontinuation were calculated.

A total of 362 patients were included in the analysis, with 160 patients in the placebo group and 202 patients in the ESL group. The occurrence of TEAEs was found to be similar between patients who received placebo (65.6%) with those who received ESL (67.8%). The largest difference in TEAE incidence occurred in the 11–21kg subgroup, with 82.6% of ESL patients experiencing a TEAE compared to 69.2% of placebo patients. 

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ESL patients reported headache, somnolence, and vomiting as the most frequently experienced TEAEs and partial seizure and status epilepticus as the most frequently experienced SAE. The overall incidence of SAEs was 9.9% for the ESL group and 5.0% for the placebo group.

The study authors also reported that “The overall incidence of TEAEs leading to discontinuation was higher with ESL (5.9%) versus placebo (2.5%); however, the incidence of each individual TEAE was = 1.0%.” Allergic dermatitis and edema were the most frequently experienced TEAEs that led to treatment discontinuation. Two deaths occurred: 1 patient in the ESL group (which was caused by cluster seizures) and 1 patient in the placebo group (which was caused by asphyxia).

“Allergic reaction TEAEs were higher in the ESL (5.0%) versus placebo (1.3%) group, with no cases of Stevens–Johnson syndrome or toxic epidermal necrolysis,” stated the authors. Additionally, hypothyroidism did not occur in many patients in either treatment group (1.0% of ESL patients and 0.6% of placebo patients) and there were no reported TEAEs of hyponatremia.

For pediatric patients with POS, treatment with ESL is generally well tolerated. The authors concluded, “The safety profile of ESL in pediatric patients is comparable to that previously reported for adult patients with POS.”

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Mintz M, et al. Safety and tolerability of adjunctive eslicarbazepine acetate in pediatric patients (aged 4-17 years) with partial-onset (focal) seizures. Presented at AES annual meeting in Washington, DC. Abstract: 3.276.