Once-Daily Adjunctive Epilepsy Treatment Zebinix® (Eslicarbazepine Acetate) Shown to be Effective, Retained and Well-Tolerated in Everyday Clinical Practice

HATFIELD, England, June 30, 2014 /PRNewswire/ --

The results of an interim analysis of the non-interventional EPOS (Eslicarbazepine acetate in Partial-Onset Seizure) study presented this week at the XXI European Congress on Epileptology (ECE) in Stockholm, Sweden, show that once-daily Zebinix^® (eslicarbazepine acetate) is effective, retained and well-tolerated when given as an add-on to anti-epileptic monotherapy to adults in routine clinical practice.^[1] Eslicarbazepine acetate, a novel anti-epilepsy treatment for adult individuals with partial epilepsy, targets sodium channels, stabilising their inactive state. It is indicated as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.^[2]

The aim of the EPOS study was to assess retention rate, effectiveness, safety and tolerability of eslicarbazepine acetate as the only add-on to monotherapy in a real world clinical setting in eight European countries (UK, Ireland, Denmark, Sweden, Norway, France, Czech Republic and Germany).^[1]

The successful treatment of partial onset seizures (the most common type of epilepsy) remains a challenge. Currently, up to a third of people with epilepsy do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.^[3]

"Many people with epilepsy are not able to achieve seizure freedom despite treatment," commented Martin Holtkamp, Principal Investigator, University Hospital Charité, Germany. "The EPOS study provides valuable insights into the use of eslicarbazepine acetate in routine clinical practice, with these interim results demonstrating that it is effective, well-tolerated and well-retained as an adjunctive therapy."

The interim analysis reviewed data from 109 adults (mean age 45.3±16.5 years; 59.6% male) with uncontrolled partial onset seizure under antiepileptic monotherapy for whom the physician had independently decided to initiate add-on treatment with eslicarbazepine acetate. The mean eslicarbazepine acetate daily dose after titration was 907.1mg±300.0 mg. Levetiracetam (32.1%) and lamotrigine (23.9%) were the most frequently preferred combination treatments.^[1]

At six-months, the eslicarbazepine acetate retention rate was 82.6%, with seizure freedom reported over the same period by 47.8% of patients.^[1] Adverse events occurred in 29 people during the observation period. The most frequently reported adverse events were dizziness (6.4%), headache (5.5%) and fatigue (4.6%).^[1]

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, England, Finland, France, Germany, Greece, Iceland, Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden, Finland, Spain (co-promotion with BIAL, the developer of eslicarbazepine acetate), Wales and the U.S**.

*Exclusively by BIAL

**Eslicarbazepine acetate is sold in the U.S. 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.^[2]

Eslicarbazepine acetate is a voltage-gated sodium channel blocker.^[4] The molecule interacts competitively with the inactive state of the sodium ion channel^[4],[5] preventing its return to the active state, and thereby inhibiting repetitive neuronal firing.^[4]The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept Phase II study^[6] and four subsequent Phase III randomised, placebo controlled studies in 1,703 adult patients with partial onset seizures refractory to treatment with one to three concomitant anti-epileptic drugs.^[2],^{[7],[8],[9],[10],[11]}

Zebinix^® is the EU trade name for eslicarbazepine acetate

Zebinix^® is under license from BIAL

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

About Epilepsy  

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide.^[12],[13] 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:

• 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
• 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)
• 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, 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
• 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  

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and 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 human health care (hhc).

Eisai concentrates its R&D activities in three key areas:

• Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight management
• Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
• Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia, Spain, Switzerland, Sweden, the Netherlands and the Middle East.

For further information please visit our web site: http://www.eisai.co.uk

About BIAL  

Founded in 1924, BIAL is an international pharmaceutical group with products available in more than 50 countries throughout four continents. BIAL is a privately held Portuguese research based pharmaceutical company and the largest Portuguese pharmaceutical company, responsible for the research and development of eslicarbazepine acetate (Zebinix^®).

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 around 20 French or Portuguese speaking African countries.

BIAL is strongly committed to therapeutic innovation investing more than 20% of its turnover in research and development every year. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy. BIAL currently has several other innovative programs under development, which the company expects to bring to the market within the next years, thereby strengthening its position throughout Europe.

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

References  

1.  Holtkamp M et al. Eslicarbazepine acetate as add-on treatment to antiepileptic monotherapy in adults with partial-onset seizures: real-world data on retention, dosing, patient reported seizure outcome and safety from an interim analysis of the open-label non-interventional study EPOS. Abstract presented at ECE 2014. P140 

2.  Zebinix , Summary of Product Characteristics (updated March 2014): http://www.medicines.org.uk/emc/medicine/22376/  

3.  Kwan P, Brodie MJ. Early identification of refractory epilepsy. New England Journal of Medicine 2000:342:314-9 

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

5.  Elger C et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers.Epilepsia 2013:54(8):1453-1461 

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):454-463 

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

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: 281-287 

10. Sperling M et al. Adjunctive Eslicarbazepine acetate in patients with seizures: efficacy result s of a 12 week randomized placebo-controlled study.  Abstract presented at AES 2013. #3.210 

11. Abou-Khalil B et al. Eslicarbazepine acetate as adjunctive therapy in patients with refractory partial-onset seizures: safety results of a 12-week randomized placebo-controlled study. Abstract presented at AES 2013. #2.128 

12. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf (accessed June 2014) 

13. 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: June 2014 
Job code: Zebinix-UK2308