The FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Aptiom (eslicarbazepine acetate, Sunovion) to include treatment of partial-onset seizures in children and adolescents four to 17 years of age. The approval was based on FDA guidance that permits the extrapolation of data to support pediatric use. The safety and efficacy of APTIOM 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 APTIOM for the treatment of POS in pediatric patients. Pharmacokinetic analyses of adult and pediatric data supported the proposed dosing regimen in the pediatric population.
Aptiom is also approved in the U.S. for the treatment of POS in adults. It is a once-daily, immediate release AED that can be taken whole or crushed, with or without food.Next Story