HATFIELD, England, June 30, 2015 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS 

New epilepsy treatment guidance, as defined by an advisory panel of experts, provides recommendations for transition to eslicarbazepine actate 

New guidance published today in Epilepsy and Behavior provides recommendations on the transition of patients from oxcarbazepine or carbamazepine to once-daily Zebinix^® (eslicarbazepine acetate) in certain clinical situations as defined by an advisory panel of experts from leading epilepsy hospitals across Europe.^[1]

"Although there is no direct head-to-head data for oxcarbazepine versus eslicarbazepine acetate or carbamazepine versus eslicarbazepine acetate, the advisory board panel agrees that alternative medication is needed for certain patients to reduce the impact of adverse events, especially neurological and cognitive adverse events, and the simple transition of eslicarbazepine acetate means that it is a potentially beneficial choice. Managing the adverse events related to anti-epileptic drugs alongside the seizures can be a challenge and we advocate the use of anti-epileptic drugs which minimise this challenge and provide patients with a good quality of life," comments Jukka Peltola, Department of neurology, neurosurgery and rehabilitation, Tampere University Hospital, Finland and co-author of the guidance.

Eslicarbazepine acetate, a once-daily anticonvulsant, is indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.^[2]

The advisory panel suggest the transition of patients who experience oxcarbazepine-related adverse events, particularly if the adverse events are most evident after morning dosing, and those who are poorly compliant with twice-daily oxcarbazepine dosing, from oxcarbazepine to eslicarbazepine acetate.^[1] This is supported by a meta-analysis of randomised, double-blind, clinical studies, which demonstrated that oxcarbazepine may be associated with more frequent neurological adverse events than eslicarbazepine acetate.^[1] In addition, they advocate transitioning patients who experience carbamazepine-related adverse events and those experiencing, or at risk of, metabolic adverse events, as well as those taking concomitant drugs with potential for interaction with carbamazepine, to eslicarbazepine acetate.^[1]

Eslicarbazepine acetate is a member of the dibenzazepine family of anti-epileptic drugs, which includes oxcarbazepine and carbamazepine. However, while eslicarbazepine acetate shares with oxcarbazepine and carbamazepine the dibenzazepine nucleus bearing the 5-carboxamide substitute, it is structurally different to these agents at the 10, 11-position.^[1] It is these structural differences which lead to differences in pharmacokinetics, pharmacodynamics and metabolism of the three drugs and give rise to the advisory board's consensus.

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, Sweden, Spain (co-promotion with BIAL), UK (co-promotion with BIAL) and the U.S***.

* Exclusively by BIAL

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

*** Eslicarbazepine acetate is sold in Russia under the trade name Exalief

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. 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.^[3] It selectively targets the slow inactivated state of the sodium ion channel^[4],[5] (which have been implicated in the pathogenesis of epilepsy),^[6] preventing its return to the active state, and thereby reduces repetitive neuronal firing.^[6] Further, eslicarbazepine acetate does not inhibit potassium efflux,^[7] which may reduce the potential for repetitive neuronal firings.^[3] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study^[8] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.^[4],[5],[6]

Zebinix^® is the EU trade name for eslicarbazepine acetate

Zebinix^® is under license from BIAL

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.^[8] 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 adult patients with partial onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL).
• Fycompa^® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older
• Inovelon^® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally developed by Novartis)
• 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 generalisation, in adults, adolescents and children aged six years and above. (Zonegran is under license from the originator Dainippon Sumitomo Pharma).

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 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^®, Exalief^®, Aptiom^®).

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. Peltola J et al . Practical guidance and considerations for transitioning patients from oxcarbazepine or carbamazepine to eslicarbazepine acetate. Epilepsy & Behaviour 2015; 50;46-49

2. Eisai Ltd 2014. Zebinix® (eslicarbazepine acetate) summary of product characteristics (last updated November 2014): http://www.medicines.org.uk/emc/medicine/22376/SPC/Zebinix+800mg+tablets/  

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

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

5. 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.

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

7. 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

8. 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 2015
Job code: Zebinix-UK2328

SOURCE Eisai