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2015 ; 8
(4
): 178-86
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A review of the efficacy and safety of eslicarbazepine acetate in the management
of partial-onset seizures
#MMPMID26136845
Rocamora R
Ther Adv Neurol Disord
2015[Jul]; 8
(4
): 178-86
PMID26136845
show ga
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.