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

Main Category: Epilepsy
Article Date: 30 Jun 2009 - 0:00 PDT

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Data presented yesterday, in Budapest, demonstrated that add-on treatment with the novel, once-daily anti-epileptic Zebinix®* (eslicarbazepine acetate; ESL) 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%). Nearly 65% of patients were classified as responders, meaning that they had achieved at least a 50% reduction in seizure frequency with Zebinix® treatment1.

"These data continue to demonstrate the efficacy and safety of Zebinix® in the treatment of partial onset seizures", said Joyce Cramer, research scientist at Yale University School of Medicine, USA and President of The Epilepsy Therapy Project. "Epilepsy is a devastating condition that can be very difficult to manage and the availability of eslicarbazepine acetate adds an important new choice of therapy for patients who are in vital need of better seizure control."

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® (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.

Zebinix®, researched and developed by BIAL, received marketing authorisation from the European Commission in April 2009, as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation. Under the terms of a deal with BIAL, announced in February this year, Eisai Europe Ltd received a sole license to market, promote and distribute ESL within Europe. Eisai and BIAL plan to launch Zebinix® across Europe during 2009 and into 2010, providing a novel and effective treatment to patients with partial-onset seizures who are not adequately controlled with their existing medications. The rights to commercialise the product in the U.S. and Canadian markets were licensed to Sepracor Inc., in late 2007 (the proposed name for eslicarbazepine acetate in the U.S. and Canada is STEDESA™). In June 2009, Sepracor announced that the U.S. Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) for STEDESA™ as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, and the NDA is currently under formal review.

Source
BIAL