Eisai and BIAL announced today that 25 abstracts, highlighting an extensive development programme for Zebinix® (eslicarbazepine acetate), have been accepted for presentation during the 29th International Epilepsy Congress, taking place in Rome from 28 August until 1 September, 2011. The presentations evaluate the use of eslicarbazepine acetate as monotherapy, its efficacy and safety in children with partial-onset seizures, its cognitive effects when used as an add-on therapy in children and its potential for use in elderly patients with partial-onset seizures*. Zebinix® is approved in Europe as adjunctive therapy for use in adults with partial-onset seizures with or without secondary generalisation. The ongoing development programme is aimed at expanding treatment options for patients with epilepsy.
“We know from previous clinical trials and ongoing clinical practice that eslicarbazepine acetate is an effective add-on therapy for adults with partial-onset seizures, with or without secondary generalisation that is easy to titrate, is well tolerated and offers once-daily dosing. These clinical trial results together with the extensive clinical trial programme highlight the potential that Zebinix® has to improve seizure control and expand its use in epilepsy,” said Professor Eugen Trinka, Universitätsklinik für Neurologie, Universität Salzburg, Austria.
A world-wide clinical study, involving 170 centres in 30 countries is ongoing, investigating the efficacy and safety of eslicarbazepine acetate as a first-line monotherapy in 900 newly diagnosed adults, in comparison to controlled-release carbamazepine. This study is in full compliance with current European guidance, and could be a pivotal development in extending treatment options for patients with epilepsy.
“These clinical trial results and planned studies reinforce Eisai and BIAL’s commitment to developing and delivering new treatments to help improve the lives of people with epilepsy. We are proud of our involvement in this field and look forward to seeing the results from studies in monotherapy, children and the elderly,” said Dr Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe.
Following the identification of eslicarbazepine acetate target doses in children, a trial is underway which aims to provide the first efficacy and safety data for eslicarbazepine acetate in the treatment of paediatric partial-onset seizures. As cognitive co-morbidity is of particular concern in children with epilepsy, due to the impact on learning and psychosocial interaction, a second paediatric study is being conducted in children and adolescents with refractory partial-onset seizures to assess the cognitive effects and safety of adjunctive eslicarbazepine acetate. Cognitive effects will be assessed using a validated cognitive test battery, and will be related to the developmental changes and disease progression occurring in the study population.
Epilepsy rates are higher in the elderly than in any other patient population; however, patients over 65 years of age are rarely included in large clinical trials due to the increased risk of side effects and the potential for altered pharmacokinetics. It has previously been shown that the pharmacokinetics of eslicarbazepine acetate are similar in both young and elderly healthy volunteers, suggesting that eslicarbazepine acetate may be a useful treatment option in this patient population. The current study aims to assess the effects of eslicarbazepine acetate on seizure frequency and safety when used as adjunctive treatment in elderly patients.
In addition to studies in specific patient populations, the use of eslicarbazepine acetate in a broader adult population has also being evaluated and presented during the IEC in Rome 2011. The results of a post-hoc analysis of the efficacy and safety in patients, with partial-onset seizures, revealed that patients refractory to ongoing treatment with carbamazepine respond well to adjunctive eslicarbazepine acetate.
It is anticipated that the new clinical trials will be completed between 2012 and 2013 and the results will help guide future treatment options for adult patients with epilepsy, as well as for specific paediatric and elderly populations.