A review of the efficacy and safety of eslicarbazepine acetate in the management of partial-onset seizures.

Abstract

Eslicarbazepine acetate is a is a once-daily antiepileptic drug (AED) that was approved in 2009 by the European Medicines Agency (EMA) (Zebinix™), and in 2013 by the US Food and Drug Administration (FDA) (Aptiom™) as adjunctive therapy in adults with refractory partial-onset seizures, with or without secondary generalization. It is a third-generation member of the dibenzazepine family of AEDs with distinctive mechanism of action, posology and tolerability profile. The eslicarbazepine acetate development program included an initial phase II study (study BIA 2-093) and three subsequent phase III, multicentre, randomized, double-blinded and placebo-controlled clinical trials (studies BIA-2093-301, BIA- 2093-302 and BIA -2093-303). A fourth phase III placebo-controlled trial (study BIA-2093-304) was designed in order to meet specific requirements of the FDA. All performed studies have consistently shown that eslicarbazepine acetate (800 to 1200 mg/day) is effective and well tolerated as adjunctive therapy for adults with partial-onset seizures.