Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

Mon, 06/29/2009 - 6:20am
Data presented today, in Budapest, demonstrated that add-on treatment with the novel, once-daily anti-epileptic Zebinix(R) resulted in a marked and sustained decrease in seizure frequency over the long-term. Results from the one-year extension of a pivotal Eslicarbazepine Acetate phase III study were presented at the International Congress for Epilepsy in Budapest, Hungary. Patients not controlled with existing anti-epileptic drugs who were given eslicarbazepine acetate as an add-on treatment experienced a mean reduction in seizure frequency of more than 61% (95%CI: -68.2%, -55.5%)1. Nearly 65% of patients were classified as responders, meaning that they had achieved at least a 50% reduction in seizure frequency with Zebinix(R) treatment. Epilepsy is one of the most common neurological diseases, affecting approximately one 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. Additional studies presented at the IEC further reinforce the efficacy and safety of eslicarbazepine acetate in the treatment of partial-onset seizures, with or without secondary generalisation. Pooled data from more than 1,000 patients enrolled in the three pivotal phase III studies demonstrated that add-on therapy with once-daily Zebinix(R) (800mg and 1200mg) was effective in reducing partial-onset seizures in patients not controlled with one of the most commonly used anti-epileptics, carbamazepine (CBZ), (p<0.01 and p<0.0001 respectively). Across the clinical studies conducted, eslicarbazepine acetate has demonstrated a favourable safety profile. This has been further reinforced by a pooled analysis indicating that most adverse events begin within the first weeks of treatment but after six weeks, no relevant difference was found between eslicarbazepine acetate and placebo. 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.

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