Beyond Seizure Control in the Treatment of Epilepsy With New Anti-Epileptic Drug, Z...(patients with epilepsy who are not achie...)

Epilepsy is one of the most common neurological diseases affecting almost one in 100 people.(12) Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge with over half of patients not achieving adequate seizure control with current anti-epileptic drugs.(13)

Zebinix(TM), a new anti-epileptic drug that selectively inhibits the rapid firing of nerve cells that causes seizures, has been developed to address the need for a new anti-epileptic agent that offers a reduction in seizure frequency combined with a favourable tolerability profile. Zebinix(TM) is currently under review by the European Medicines Agency (EMEA) for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs. A U.S. New Drug Application (NDA) is currently being prepared with an anticipated submission to the U.S. Food and Drug Administration in early 2009.

About the trials

The three phase III, multi-centre, randomised, placebo controlled trials involved an aggregate of more than 1,000 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.(8)

During the trials, patients were randomised to various dosages of eslicarbazepine acetate 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.(2)-(11)

Efficacy

Over the 12 week maintenance period, Zebinix(TM) 800mg and 1200mg once-daily reduced seizure frequency by over one third, and was significantly more effective than placebo. This significant decrease in seizure frequency was sustained over the one-year open label treatment period and
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