New Data for Once-daily Adjunctive Zebinix® (eslicarbazepine acetate) Show Good Seizure Control and Tolerability in People With Partial Onset (Focal) Seizures

PORTO, Portugal and HATFIELD, England, December 4, 2016 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/US JOURNALISTS    

Zebinix^® (eslicarbazepine acetate) provides a high retention rate, reduction in seizure frequency and seizure freedom with a favourable adverse event profile and an improved global clinical impression of change (CGI-C) and severity (CGI-S) when used as adjunctive therapy in people with partial onset (focal) seizures with or without secondary generalisation, according to the ESLADOBA study presented today at the American Epilepsy Society (AES) Houston, US.^[1]

Eslicarbazepine acetate is indicated in the European Union as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.^[2]

The two-year, multi-centre, non-interventional, prospective cohort study included 52 patients (≥18 years) at 12 neurology departments in Portugal with partial onset (focal) seizures insufficiently controlled with one anti-epileptic drug (AED), who had initiated eslicarbazepine acetate as adjunctive treatment. The primary endpoint was the retention rate, defined as the proportion of patients remaining on eslicarbazepine acetate treatment at the end of follow up. Secondary endpoints included the proportion of responders (patients with at least 50% reduction in seizure frequency compared to baseline), proportion of seizure-free patients and the change in frequency for partial seizures with or without secondary generalisation.^[1]

In the ESLADOBA study, the retention rate was 73.0% (95% CI, 61.0-85.2). The responder rate and the rate of seizure freedom were 71.1% (95% CI, 56.7-85.5) and 39.5% (95% CI, 24.0-55.0), respectively. The seizure-free rate found in secondarily generalised seizures was 94.7% at final assessment. The median relative reduction in seizure frequency between baseline and final assessment was 82.2% (the mean time between initial and final assessment was 7.8 months).^[1]

A reduction in epilepsy severity was observed in 42.1% of patients and 73.6% of patients had their epilepsy "much improved" or "very much improved" and there were no cases where epilepsy was considered to be worse, according to the global clinical impression of change (CGI-C) and severity (CGI-S), which was recorded by neurologists.

In this study, 23.1% (n=12) of patients experienced at least one adverse event and 19.2% (n=10) had at least one AE that was judged to be related to the study drug; 3.9% (n=2) had at least one serious adverse event. The majority adverse events were classified as mild to moderate intensity (n=14) and (n=9) were classified as severe.^[1] Five patients were withdrawn from the study due to AEs.

"The ESLADOBA study shows that once-daily, adjunctive eslicarbazepine acetate showed good retention rates and elicits a significant reduction in seizure frequency in patients with partial onset seizures not sufficiently controlled with monotherapy," comments Dr João Chaves, Neurologist, Santo Antonio Hospital, Centro Hospitalar Porto.

"Data recorded in routine clinical practice is vital to help inform our understanding of how treatments work in the real world. These findings suggest effective seizure control and favourable tolerability of eslicarbazepine acetate adjunctive treatment in this setting," Patrício Soares-da-Silva, Director of Research & Development, Bial, Porto, Portugal.

"These data underscore our commitment to support people with epilepsy to better manage their condition and live their lives to the full. We are encouraged by these data and will ensure that eslicarbazepine acetate continues to play an important role in the treatment of epilepsy for the thousands of people in Europe who live with the condition," comments Neil West, Vice President, Global Neurology Business Unit, Eisai.

Notes to Editors   

About Zebinix^® (eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel (which have been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing.^[3] Further, eslicarbazepine acetate does not inhibit potassium efflux, which may reduce the potential for repetitive neuronal firings.^[4] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study^[5] and three subsequent phase III randomised, placebo controlled studies in 1,049 people with refractory partial onset seizures.^[6],[7],[8]

Eslicarbazepine acetate is currently marketed in Europe and Russia by Bial and Bial's licensee, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd. under the trade name Zebinix^® or Exalief^®. In the United States and Canada eslicarbazepine acetate (tradename Aptiom^®) is marketed by Sunovion Pharmaceuticals Inc., under an exclusive license from Bial.

About Epilepsy    

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 6 million people in Europe, and an estimated 50 million people worldwide.^[9],[10] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.

About Bial    

Founded in 1924, Bial's mission is to discover, develop and provide therapeutic solutions within the area of health. In recent decades, Bial has strategically focused on quality, innovation and internationalisation.

Being the partner of choice for many pharma companies, Bial is strongly committed to therapeutic innovation, investing more than 20% of its turnover in Research and Development (R&D) every year.

Bial has established an ambitious R&D programme centred in neurosciences, cardiovascular system and allergic immunotherapy. The company expects to continue to introduce new medicines and vaccines to the market in the next years, strengthening its position worldwide and accomplishing the company's purpose of "Caring for your Health."

For more information about Bial, please visit http://www.bial.com .

About Eisai Co., Ltd.    

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology. 

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com

References    

1.    Chaves J et al. Seizure control and tolerability of eslicarbazepine acetate as adjunctive therapy in adults with partial-onset seizures in routine clinical practice - ESLADOBA Study. Presented at American Epilepsy Society 2016 

2.    Zebinix® (eslicarbazepine acetate) Summary of Product Characteristics (SmPC) - Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000988/C500047225.pdf Accessed November 2016 

3.    Hebeisen S, et al. Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: a comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 2015; 89:122-35 

4.    Soares-da-Silva P, et al. Eslicarbazepine acetate for the treatment of focal epilepsy: an update on its proposed mechanisms of action. Pharmacol Res Perspect. 2015; 3:e00124 

5.    Elger C, et al. Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia.2007; 48:497-504 

6.    Elger C, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50:454-63 

7.    Ben-Menachem E, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-85 

8.    Gil-Nagel A, et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in  adults with refractory partial-onset seizures. Acta Neurol Scand. 2009; 120:281-87 

9.    Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf Accessed November 2016 

10.   Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia. 2007:48(12):2224-33 

December 2016

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