Epilepsy drug receives approval as monotherapy from European Medicines Agency

Zebinix (eslicarbazepine acetate) has received approval from the European Medicines Agency as a once-daily monotherapy in adults with newly diagnosed partial-onset epilepsy. Eslicarbazepine acetate is already used in Europe as an adjunctive therapy in patients over 6 years of age with partial-onset seizures. Following the results of a Phase III trial, this latest approval of the drug as a monotherapy was announced by Bial (Porto, Portugal) and Eisai (Kamisu, Japan). The Phase III, randomized, double-blind, active-controlled study compared once-daily eslicarbazepine acetate as a monotherapy with twice-daily, controlled-release carbamazepine in adults newly diagnosed with partial-onset seizures. The data demonstrated that 71.1%...