New Analyses of Real World Data Presented at the American Epilepsy Society (AES) Annual Meeting on Use of Zebinix® (Eslicarbazepine Acetate) to Manage Partial-Onset Seizures

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Eisai

07 Dec, 2015, 00:01 GMT

HATFIELD, England, December 7, 2015 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR AUSTRIAN/SWISS/US JOURNALISTS  

Real-world data at The American Epilepsy Society (AES) 69th Annual Meeting, Philadelphia, report that when Zebinix® (eslicarbazepine acetate) was used as an add-on to antiepileptic monotherapy in 45 people with partial-onset seizures, who had a documented non-response to carbamazepine, after 6 months, the retention rate was 88.9% (95%CI 75.9 - 96.3%, n=45).[1]

AES represents a significant milestone for eslicarbazepine acetate, with 19 abstracts to present over four days with two important sub analyses from a European real-world study. This is the largest number of abstracts for eslicarbazepine acetate at a single congress which demonstrates its strong scientific presence in epilepsy.

The post hoc subgroup analysis examined data from the EPOS (Eslicarbazepine acetate in Partial-Onset Seizure) study programme, a multicentre evaluation of 247 people with partial-onset seizures across eight European countries over six months. Responder rates and seizure freedom rates in the eslicarbazepine acetate arm were 95.1% (95% CI 83.5-99.4%; n=41) and 33.3% (95% CI 19.6-49.5%, n=42) respectively. Mean QOLIE-10 score decreased from 2.8 (n=21) at baseline to 2.2 (-13.0%; n=18) after 6 months.[1] A decreasing QOLIE-10 score is a measure of improvement in quality of life.

"People with partial-onset seizures may try several therapies before they find one they respond to. This data shows that a good proportion of people with partial-onset seizures, who have not responded when treated with carbamazepine, may respond to eslicarbazepine acetate. The results of the study further highlight the importance of trying different treatment options," comments Professor Martin Holtkamp from the University Hospital Charité, Germany.

A further post-hoc analysis of the EPOS study was conducted to evaluate eslicarbazepine acetate as an add-on treatment to antiepileptic monotherapy for people with partial-onset seizures aged 60 and over. After six months of treatment with eslicarbazepine acetate, retention, responder and seizure freedom rates were 78.0%, 83.3 and 56.3% respectively.[2] Other assessments in this analysis included patient-rated quality of life, where a mean QOLIE-10 score decreased from 2.7 (n=28) at baseline to 2.2 (-14.5%; n=24) after six months.[2]

"We are proud to share these data on the use of eslicarbazepine acetate to manage partial-onset seizures. Eisai are committed to the exploration of effective treatments for people affected by epilepsy," comments Neil West, Vice President, Global Neurology Business Unit, Eisai EMEA.

The continued development of eslicarbazepine acetate underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eslicarbazepine acetate is already available in Albania*, Austria, Czech Republic, Cyprus*, Denmark, Finland, France, Germany (co-promotion with BIAL, the developer of eslicarbazepine acetate), Greece, Iceland, Italy, Malta*, Norway, Portugal*, Republic of Ireland, Russia, Scotland, Slovakia, Sweden, Spain (co-promotion with BIAL), UK (co-promotion with BIAL) and the U.S and Canada**.

*Exclusively by BIAL

**Eslicarbazepine acetate is sold in the U.S. and Canada under the trade name APTIOM®

Notes to Editors   

About Zebinix® (eslicarbazepine acetate)

Eslicarbazepine acetate is currently marketed in Europe by BIAL-Portela & Cª, S.A and by BIAL's licensee, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd. under the trade name Zebinix®. In the United States and Canada eslicarbazepine acetate (tradename Aptiom®) is marketed by Sunovion Pharmaceuticals Inc., under an exclusive license from BIAL.

Eslicarbazepine acetate is indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.[3] The clinical trial programme is also underway for eslicarbazepine acetate as a paediatric and monotherapy treatment.

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.[4] Further, eslicarbazepine acetate does not inhibit potassium efflux, which may reduce the potential for repetitive neuronal firings.[5] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[6] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.[7],[8],[9]

  • Zebinix® is the EU trade name for eslicarbazepine acetate
  • Zebinix® is under license from BIAL
  • APTIOM® is the trade name for eslicarbazepine acetate in the U.S. and Canada and is under license to Sunovion Pharmaceuticals Inc.

For more information please visit: http://www.eisai.co.uk

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.[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 Eisai EMEA in Epilepsy   

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation (Zebinix is under license from BIAL). Eisai received a sole license to market, promote and distribute Zebinix® in the following European Countries: Austria, Belgium, Bulgaria, Czech Republic, Belarus, Bosnia, Croatia, Denmark, Estonia, Finland, France, Germany (co-promotion with Bial since May 2015), Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, Netherlands, Norway, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Spain (co-promotion with Bial from launch) Sweden, Switzerland, Turkey, Ukraine and the United Kingdom (co-promotion with Bial since July 2015)
  • Fycompa® (perampanel) for the adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older. Fycompa is also indicated for the treatment of primary generalised tonic-clonic (PGTC) seizures in adults and adolescents (≥12 years) with idiopathic generalised epilepsy (IGE)
  • Zonegran® (zonisamide) as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
  • Inovelon® (rufinamide) for the adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients four years of age and older (Rufinamide was originally developed by Novartis)

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.

About BIAL   

Founded in 1924, BIAL is an international pharmaceutical company with the mission to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has focused on quality, innovation and internationalization.

Being the partner of choice for many 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 program centred on the central nervous, cardiovascular system and allergy immunotherapy. BIAL's innovative programmes focus on continuing the clinical development of its anti-epileptic Zebinix®/Aptiom® (on the market in Europe and the US). A second compound from its R&D pipeline for the treatment of Parkinson's disease is under review by the European Medicines Agency (EMA).

The company expects to introduce more 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.

References   

  1. McMurray et al. Eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in patients with partial-onset seizures who previously did not respond to carbamazepine: real-world evidence from the EPOS study. Presented at AES 2015
  2. Karlsson et al. Real-world data on eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in elderly patients (>60 years) with partial-onset seizures. Presented at AES 2015
  3. Zebinix® Data on File, May 2015
  4. 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; 89:122-135
  5. 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(2):e00124
  6. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on, Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset Seizures. Epilepsia 2007; 48(3):497-504)
  7. Elger C et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomized, double-blind, placebo-controlled, parallel-group phase III study Epilepsia. 2009;50(3):454-63
  8. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-85
  9. 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(5):281-7
  10. Pugliatti M, et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007; 48(12) 2224-2233


Date of preparation: November 2015
Job code: Zebinix-UK2366