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Novel Once Daily Anti-Epileptic Zebinix(R) Approved in the European Union
Date:4/27/2009

S.MAMEDE DO CORONADO, Portugal and LONDON, April 28 /PRNewswire/ --

- New Option for Treatment of Epilepsy Patients With Partial Onset Seizures

Bial-Portela & CA, S.A., (S. Mamede do Coronado, Portugal, President & CEO Dr Luis Portela), and Eisai Europe Limited (London; Chairman & CEO Yutaka Tsuchiya), the European subsidiary of Eisai Co., Ltd. (Tokyo, President & CEO: Haruo Naito), today announced that the novel once daily anti-epileptic Zebinix(R)* (eslicarbazepine acetate) received marketing authorisation from the European Commission as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.

Epilepsy is one of the most common neurological diseases, affecting approximately 1 in 100 people. Treatment of partial-onset seizures, the most common type of epilepsy, remains a constant challenge and up to 40% of patients with partial seizures do not achieve seizure control with current anti-epileptics(1).

The efficacy, safety and tolerability of eslicarbazepine acetate (ESL) has been demonstrated in three phase III double-blind, randomised placebo-controlled trials in 1,049 patients with partial onset seizures(2-4). For each randomised control trial patients were given the option of entering a one year open label extension study.

ESL demonstrated significant and sustained reductions in seizure frequency and significant increases in responder rates (greater than or equal to 50% decrease in seizure frequency.) These studies also demonstrated that patients continued to take ESL with retention rates ranging from 68-79% at one year(5-7). The median daily dose throughout this one year treatment was 800mg. Treatment-emergent adverse events affecting >10% of patients in the pivotal studies were dizziness, headache and somnolence(8).

The studies found that patients taking ESL also showed statistically si
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SOURCE Bial and Eisai
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