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

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Rocamora R

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

Ther Adv Neurol Disord. 2015 Jul;8(4):178-86. doi: 10.1177/1756285615589711.

PubMed ID
26136845 [ View in PubMed
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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.

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