Final EPOS Study Results Presented at the International Epilepsy Congress (IEC) Show That Adjunctive Zebinix® (eslicarbazepine acetate) Improves Quality of Life

HATFIELD, England, September 9, 2015 /PRNewswire/ --

Study results show that once-daily 800mg eslicarbazepine acetate has high retention rates as adjuvant treatment in epilepsy 

Final results of the non-interventional EPOS (Eslicarbazepine acetate in Partial-Onset Seizure) study, presented at the International Epilepsy Congress (IEC) in Istanbul, show that when once-daily eslicarbazepine acetate is added to a monotherapy there are resultant beneficial effects on patient-rated quality of life (QOLIE-10) and clinician-rated improvement (CGI-GI).^[1] Average patient-rated quality of life score decreased from 2.9 (n=128) at baseline to 2.4 (-14.6%; n=114) after 3 months and 2.1 (-20.8%; n=109) after 6 months.^[1] The majority of patients have shown to be 'much improved' or 'very much improved' on the clinician-rated improvement after 3 months (64.7%; n=211) and 6 months (75.6%; n=192).^[1]

Additional EPOS study programme data presented at IEC show that eslicarbazepine acetate is effective and well tolerated in clinical settings, regardless of the monotherapy that is added.^[2] Retention rates (95% confidence intervals) at 6 months when in combination with eslicarbazepine acetate  are 100% (76.8-100.0%) for carbamazepine (CBZ), 85.5% (76.1-92.3%) for levetiracetam (LEV), 80.0% (61.4-92.3%) for valproate (VAL) and 75.9% (62.4-86.5%) for lamotrigine (LTG). Responder rates at 6 months are 92.9% (CBZ), 88.5% (VAL), 81.9% (LEV) and 69.8% (LTG).^[2]

"These data show that eslicarbazepine acetate is a suitable add-on to antiepileptic monotherapy in routine clinical practice and results in significant and tangible benefits for people with epilepsy, on a day-to-day basis," comments Martin Holtkamp, Principal Investigator, University Hospital Charité, Germany.

Eslicarbazepine acetate, indicated in Europe as adjunctive therapy in adults with partial onset seizures with or without secondary generalization,^[3] is a novel once-daily sodium channel blocker that differentially and selectively targets slow inactivated sodium channels. Eslicarbazepine acetate was approved by the European Commission in 2009 based on data submitted that shows it reduces seizure frequency by up to 45% in patients with partial epilepsy.^[4],[5],[6]  

Epilepsy is one of the most common neurological conditions, affecting approximately 6 million people in Europe.^[7] Despite the many anti-epileptic drugs (AEDs) available, the successful treatment of partial onset seizures remains a challenge in some patients. Currently, between 20-40% of patients with newly diagnosed epilepsy will become refractory to treatment.^[8]

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 indicated 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.^[9] It selectively targets the slow inactivated state of the sodium ion channel^[10] (which have been implicated in the pathogenesis of epilepsy),^[11] preventing its return to the active state, and thereby reduces repetitive neuronal firing.^[11] Further, eslicarbazepine acetate does not inhibit potassium efflux, which may reduce the potential for repetitive neuronal firings.^[11] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study^[12] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures^[4],[5],[13].

• 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.
  

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.^[14] 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's mission is to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has focused on quality, innovation and internationalization. It is the partner of choice for many companies, having a strong presence in the Iberian Peninsula as well as in over 10 countries in Latin America and in several French- or Portuguese-speaking African countries.

BIAL is strongly committed to therapeutic innovation, investing more than 20% of its turnover in research and development (R&D) every year, placing it among the most innovative European companies. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy.

BIAL's innovative programmes focus on continuing the clinical development of its anti-epileptic Zebinix/Aptiom (on the market in Europe and the USA), as well as opicapone for Parkinson's disease.

With a team of 900 employees, BIAL has reinforced its international presence, an aspect that the company will strengthen over the next decade.

Further information about BIAL can be found at http://www.bial.com

References  

1. Kerr et al. Impact on quality of life and clinician-related global improvement with eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in adults with partial-onset seizures. 31st International  Epilepsy Congress 2015

2. Derambure P et al. Eslicarbazepine acetate as add-on to antiepileptic monotherapy in adults with partial onset seizures (EPOS study): analysis by baseline antiepileptic drug. 31st International  Epilepsy Congress 2015

3. Eisai Ltd 2015. Zebinix® (eslicarbazepine acetate) summary of product characteristics (last updated May 2015): http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets/

4. 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):454-463

5. Ben-Menachem E et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010; 89:278-285

6. 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; 120:281-287

7. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae.org/Visitors/Documents/ILAEAnnual-Report2010Final_000.pdf (Accessed January 2015)

8. French JA. Refractory Epilepsy; Clinical Overview. Epilepsia 2007; 48 (Suppl1) 3-7

9. Almeida L, Soares-da-Silva P. Eslicarbazepine Acetate (BIA 2-093). Neurotherapeutics 2007 Jan; 4(1):88-96

10. 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 Feb; 89:122-135. Doi 10.1016/j.neuropharm.2014.09.008

11. Vilin YY and Ruben PC. Slow Inactivation in Voltage-Gated Sodium Channels. Cell Biochem Biophys 2001; 35(2):171-190

12. 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

13. Sperling MR et al. Eslicarbazepine acetate as adjunctive therapy in patients with uncontrolled partial-onset seizures: Results of a phase III, double-blind, randomized, placebo-controlled trial. Epilepsia 2015; 56(2):244-53

14. 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: August 2015
Job code: Zebinix-UK2342