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.