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Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)
Date:6/28/2009

highly prevalent with existing anti-epileptic agents and may affect as many as 97% of patients(7). Hence, there is a need for new anti-epileptic agents that offer effective reduction in seizure frequency combined with a favourable safety profile.

About Eslicarbazepine Acetate

Eslicarbazepine acetate (ESL) is a novel once-daily voltage-gated sodium channel blocker designed to selectively inhibit the rapid firing of nerve cells that causes seizures. It specifically targets the inactivated state of the ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing. The efficacy of ESL has been demonstrated in three randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures. ESL also significantly improved patient's health related quality of life (HRQoL) as measured by the QOLIE-31 score during a one year open label extension of the above 3 studies. ESL is given orally once-daily. ESL can be used as an add-on to carbamazepine (one of the most commonly utilized therapies for partial onset seizures) or with other anti-epileptics.

Clinical data

The EU approval was based on data from phase II and three phase III, double-blind, randomised, placebo-controlled, multi-centre trials involving 1,192 patients from 23 countries. Patients had a history of at least four partial seizures per month despite treatment with up to three concomitant anti-epileptic drugs.

During the trials, patients were randomised to various dosages of ESL or placebo and after a 2-week titration period, were assessed over a 12 week maintenance period, with continued follow-up over a one year open-label period.

Efficacy

Over the 12 week maintenance period, ESL 800mg and 1200mg once-daily reduced seizure frequency by over one third, and was significantly more effective than placebo. This significant decrease in seiz
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