Eisai and BIAL will present new research on Zebinix ® data at the International Congress of epilepsy

HATFIELD, United Kingdom, August 29, 2011/PRNewswire /-

have been accepted 25 abstracts for presentation

Eisai and BIAL announced today that 25 abstracts that highlight the extensive program of development of Zebinix ® (eslicarbacepina acetate), have been accepted for presentation during the 29 International Congress of epilepsy to be held in Rome from August 28 to September 1, 2011. Presentations evaluating the use of acetate eslicarbacepina as monotherapy, its efficacy and safety in children with crisis of partial onset, cognitive effects as complementary therapy in children and their possible use in elderly patients with partial onset seizures *. Zebinix ® (eslicarbacepina acetate) is approved in Europe as adjuvant therapy for use in adults with partial onset seizures, with or without secondary generalization.[1] The continuous development programme is aimed to expand treatment options for patients with epilepsy.

We know from previous clinical trials and clinical practice continuous eslicarbacepina acetate is an effective complementary therapy for adults with partial onset seizures, with or without secondary generalization, whose dose is easy to adjust, well tolerated and allows to manage a single daily dose. The results of these clinical trials, together with the extensive program of clinical trials, highlights the potential of Zebinix ® to improve seizure control and expand its use in epilepsy. ” Professor Eugen Trinka, Universitätsklinik für Neurologie, Universität Salzburg, Austria.

A clinical trial involving 170 centres in 30 countries to investigate the efficacy and safety of acetate again diagnostic eslicarbacepina as monotherapy first-line 900 adults, compared with the controlled-release carbamazepine globally is being conducted. This study fully complies with current European guidelines and can be an essential step to broaden the options of treatment of patients with epilepsy.

The results of this study and other planned studies reinforce of Eisai and BIAL commitment to the development and commercialization of new treatments that help improve the lives of people with epilepsy. We are proud of our commitment in this area and look forward to seeing the results of studies in monotherapy, children and elderly ”, says the DRA. Bettina Bauer, Director of the epilepsy for the EU, Eisai Europe business unit.

After the identification of the target dose of acetate of eslicarbacepina in children, being an essay which proposes to offer the first data on the efficacy and safety of acetate eslicarbacepina in the treatment of Pediatric partial onset seizures. As cognitive comorbidity has special significance in children with epilepsy, because of its effects on learning and psycho-social interaction, is being conducted a second Pediatric study in children and adolescents with treatment resistant partial onset seizures for assessing cognitive effects and safety of adjuvant eslicarbacepina acetate. The effects of cognitive using the UBC, a battery of cognitive tests validated, will evaluate and will link with evolutionary changes and progression of the disease occur in the population of the study.

Epilepsy rates are higher in the elderly than in any other patient population; However, rarely includes patients with more than 65 years in large clinical trials due to the increased risk of side effects and the possibility of Pharmacokinetic disturbances. It has previously demonstrated that the pharmacokinetics of eslicarbacepina acetate is similar in young healthy volunteers and in the elderly, suggesting that eslicarbacepina acetate can be a useful treatment in this patient population option. The current study aims to assess the effects of acetate eslicarbacepina on the frequency of crises and their safety when used as adjunctive therapy in elderly patients.

Studies in specific patient populations, also the use of eslicarbacepina acetate in a wider adult population has been evaluated and the results will be presented at the Rome 2011 CIS. The results of an analysis a posteriori of the efficacy and safety in patients with partial onset seizures showed patients continuing treatment with carbamazepine resistant to respond well to adjuvant eslicarbacepina acetate.[2]

Is anticipated that the trials are concluded between 2012 and 2013 and the results will help guide future treatment options for adults with epilepsy patients, as well as for the specific populations of pediatric patients and elderly.