Eslicarbazepine Receives FDA Nod for Expanded Indication for the Treatment of Partial-Onset Seizures in Children

FDA permits extrapolation of adult trial data to support pediatric use

The FDA has approved a supplemental new drug application expanding the indication for eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) to include treatment of partial-onset seizures (POS) in children and adolescents 4 to 17 years of age. Eslicarbazepine is also approved in the U.S. for the treatment of POS in adults. The treatment is administered as a once-daily, immediate release tablet.

“Despite being the most common seizure type in patients with epilepsy, there continues to be a critical need for new therapeutic options for partial-onset seizures, especially for children and adolescents,” said Steven Wolf, MD, Director of Pediatric Epilepsy and Associate Professor of Neurology at Mount Sinai Health System in a press release. “The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends, and community. It is important that physicians have additional treatment options that address patient needs.”

The approval to expand eslicarbazepine’s indication to include children 4 years of age and older is based on FDA guidance that permits the extrapolation of data to support pediatric use. The safety and efficacy of eslicarbazepine as monotherapy and adjunctive therapy for the treatment of POS in adults was established in five multicenter, randomized, controlled clinical trials. Data from three clinical trials conducted by Sunovion’s partner BIAL also supported the safety and tolerability of eslicarbazepine for the treatment of POS in pediatric patients. Pharmacokinetic analyses of adult and pediatric data supported the proposed dosing regimen in the pediatric population.

The initial research and development of eslicarbazepine was performed by BIAL, a privately held Portuguese research-based pharmaceutical company. Sunovion acquired the rights to eslicarbazepine in the U.S. and Canadian markets under an exclusive license from BIAL.

The most common adverse reactions in adult patients include dizziness, sleepiness, nausea, headache, double vision, vomiting, feeling tired, problems with coordination, blurred vision, and shakiness. Side effects seen in pediatric patients are similar to those seen in adult patients.

Source: Sunovion; September 14, 2017.