Welcome!

News Feed Item

New Studies on Zebinix® Presented at Leading European Epilepsy Congress

HATFIELD, England, October 3, 2012 /PRNewswire/ --

Bial and Eisai today present information on new studies designed to increase the understanding of the use of Zebinix® (eslicarbazepine acetate), a once-daily adjunctive therapy for adults with partial-onset seizures, with or without secondary generalisation, at the 10th European Congress on Epileptology (ECE) in London.[1]

These new data will be important as the successful treatment of partial-onset seizures remains a challenge, and up to a third of people with epilepsy do not achieve freedom from seizures despite appropriate therapy with anti-epileptic drugs.[2]

Eslicarbazepine acetate in Partial-Onset Seizures study (EPOS)[3]

Launched in March 2012, the Eslicarbazepine acetate in Partial-Onset Seizures (EPOS) study design presented here aims to provide a better understanding of the use of eslicarbazepine acetate in a clinical practice setting.  EPOS is a prospective, multicentre, open-label, non-interventional study of adults with partial-onset seizures insufficiently controlled by monotherapy anti-epileptic treatment.  The goal is to recruit approximately 800 patients from over 200 centres in Denmark, France, Germany, Norway, Sweden and the UK. The study primary endpoint will be 6-month retention rate and other assessments will include seizure frequency, adverse events and quality of life.  

"The significant number of people with epilepsy who fail to achieve seizure control necessitates the need for on-going investigations in real life settings," commented Martin Holtkamp, EPOS Principal Investigator from the University Hospital Charité, Germany. "Our non-interventional study will increase our knowledge of eslicarbazepine acetate's efficacy and tolerability in routine practice when used to treat adults who are less refractory than those included in standard Phase III adjunctive therapy clinical trials.  This will be very valuable information."

Eslicarbazepine acetate is currently licenced as an adjunctive treatment for adults with partial-onset seizures, with or without secondary generalisations (where the seizure extensively affects a patient's consciousness by spreading to both sides of the brain).[1] It is not yet known whether eslicarbazepine acetate will demonstrate efficacy and tolerability if used as a monotherapy and in newly diagnosed patients. To address this question, also presented today is the design of a Phase III, double-dummy, active controlled, multinational non-inferiority monotherapy trial of eslicarbazepine acetate versus controlled-release carbamazepine in adults with partial-onset seizures.[4]

This study will enrol newly diagnosed epilepsy patients ≥18 years of age with documented partial-onset seizures and randomise in a 1:1 ratio.

Paediatric patients sometimes require specific dosing regimens, and additional safety and tolerability evidence beyond that available for adult populations is required. Eslicarbazepine acetate, which does not have a paediatric licence, is currently under investigation in a paediatric patient population for adjunctive use in partial-onset seizures in Europe.[5] The study aims to assess the efficacy and safety of eslicarbazepine acetate as adjunctive therapy in 252 children and adolescents (2 - 18 years old).[5]

There are a further 16 posters presented within this congress, many of which examine the pharmacokinetic and pharmacodynamic information pertaining to eslicarbazepine acetate.

"It is great to see so many studies presented here at the ECE. The abstracts which focus on the pharmacokinetic and pharmacodynamic information will also help doctors build up a much clearer picture of eslicarbazepine acetate," said Professor Eugen Trinka from the Department of Neurology, Paracelsus Medical University, Salzburg, Austria.  

Approved in Europe in 2009, Zebinix is currently available in Albania*, Austria, Czech Republic, Cyprus*, Denmark, England, Finland, France, Germany, Greece, Iceland, Malta*, Norway, Portugal*, Republic of Ireland, Scotland, Sweden, Spain (co-promotion with BIAL, the developer of Zebinix®) and Wales.

*Exclusively by BIAL

Notes to Editors

Zebinix® is the EU trade name for eslicarbazepine acetate

Zebinix® is under license from BIAL

About epilepsy, partial-onset seizures and their treatment

Epilepsy is a chronic neurological disease characterised by abnormal discharges of neuronal activity causing seizures. Depending on the seizure type, seizures may be limited to one part of the body, or may be generalised to involve the whole body. Patients may also experience abnormal sensations, altered behaviour or altered consciousness. Epilepsy is a disorder with many possible causes. Often the cause of epilepsy is unknown. However, anything that disturbs the normal pattern of neuron activity - from illness to brain damage to tumours, can lead to seizures.[6]

Epilepsy is characterised by abnormal firing of impulses from nerve cells in the brain. In partial-onset seizures, these bursts of electrical activity are initially focused in specific areas of the brain,[7] but may become more generalised, the symptoms vary according to the affected areas.[8]

Epilepsy is one of the world's most common neurological disorders, affecting more than six million people across Europe.[9] With significant health care costs and economic impacts[10], uncontrolled seizures also increase the risk of psychological comorbidities, such as anxiety and depression.[11]

About Zebinix®(eslicarbazepine acetate)

Eslicarbazepine acetate is a voltage-gated sodium channel blocker.[12] It preferably targets the inactivated state of the sodium ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing.[12] Recent studies have also demonstrated that eslicarbazepine acetate effectively inhibits voltage-gated calcium channels, therefore enhancing its potential as an anti-epileptic agent.[13] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[14] and three subsequent phase III randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.[15],[16],[17]

Clinical data

The EU approval was based on data from a phase II and three phase III clinical trials.[11],[12],[13],[14] Patients recruited in the phase III trials had a history of at least four partial seizures per month despite treatment between one to three concomitant anti-epileptic drugs.[12],[13],[14]

During the trials, patients were randomised to various dosages of Zebinix® or placebo and after a 2-week titration period, were assessed over a 12-week maintenance period, with continued follow-up over a one year open-label period.[12],[13],[14],[18],[19],[20]

Efficacy

Over the 12-week maintenance period, Zebinix® 800mg and 1200mg once-daily significantly reduced seizure frequency, and was significantly more effective than placebo.[11],[12],[13],[14]  Long-term safety and maintenance of therapeutic effect was demonstrated in one-year open-label extensions of these studies.[15],[16],[17]

Tolerability[11],[12],[13],[14]

In the Phase III clinical trials adverse events mainly occurred during the first 6 weeks of treatment and the majority of patients experienced adverse events of mild to moderate intensity. After the initial 6 weeks of treatment there were no observed differences in the incidence of side effects between patients treated with Zebinix® and the placebo group. The most common treatment-emergent adverse events in the pivotal studies were dizziness, headache and somnolence.

License Agreement

Eisai Europe Limited (Headquarters: London, President & CEO: Gary Hendler), a European subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito), announced in February 2009 that it had entered into a license and co-promotion agreement with BIAL - Portela & Cª, S.A. (Headquarters: São. Mamede do Coronado, Portugal, Chairman: Luís Portela & CEO: António Portela, "BIAL"), which gave Eisai Europe Limited rights to sell BIAL's anti-epileptic drug Zebinix®(eslicarbazepine acetate) in Europe.

About Eisai Europe 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 and Russia (EMEA).

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

  • Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
  • Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years
  • 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

About Eisai:

Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.

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

  • Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
  • 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 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.

For further information please visit our web site 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, based in S. Mamede do Coronado, Portugal, responsible for the research and development of eslicarbazepine acetate (Zebinix®).

It is the partner of choice for many pharma 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. Summary of Product Characteristics Zebinix® (eslicarbazepine acetate)(updated November 2011)    

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

3. Holtkamp et al.  Design of the EPOS Study.  An Open Label Multicentre, Non-Interventional Study to Evaluate Eslicarbazepine Acetate as Adjunctive Treatment to One Baseline Antiepileptic Drud in Adults with Partial Onset seizures.  ECE 2012 abstract p665

4. J. Moreira et al. Design of a Phase III, double-dummy, active-controlled, multi-national non-inferiority monotherapy trial of eslicarbazepine acetate versus controlled-release carbamazepine in adults with partial-onset seizures. Abstract ECE 2012 (p415).

5. F. Mota et al. A clinical study method used to evaluate the efficacy and safety of novel antiepileptic drug eslicarbazepine acetate in epileptic children with partial-onset seizures. Abstract ECE 2012 (p175).

6. Epilepsy Research UK. What is Epilepsy? Fact sheet.: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (accessed March 2012)

7. Epilepsy Action. Describing Seizure Types.  http://www.epilepsy.org.uk/info/seizures/ataglance (Accessed March 2012)

8. NHS Choices. Symptoms of Epilepsy.  http://www.nhs.uk/Conditions/Epilepsy/Pages/Symptoms.aspx (Accessed March 2012)

9. Epilepsy must become a higher priority in Europe. The Lancet Neurology. 2010 Oct; 9(10): 941

10. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modelling. Epilepsia 2007: 48(12) 2224 - 2233.

11. Titlic, M. Basic, S. Hajnek, S. Comorbidity psychiatric disorders in epilepsy: a review of literature. Bratisl Lek Listy (Bratislava Medical Journal) 2009; 110 (2): 105 - 109

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

13. Brady K et al. The effects of Eslicarbazepine, R-Licarbazepine, Oxcarbazepine and Carbamazepine on ion transmission through Cav3.2 channels.  Abstract presented at International Epilepsy Congress 2011 p858.

14. Elger et al. Eslicarbazepine Acetate: A Double-blind, Add-on Placebo-controlled Exploratory Trial in Adult Patients with Partial-onset seizures. Epilepsia, 48(3):497-504, 2007

15. Elger C, Halász P, Maia J 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

16. Ben-Menachem E, Gabbai A, Hufnagel A, Maia J, Almeida L, Soares-da-Silver P. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010;89:278-285.

17. Gil-Nagel A, Lopes-Lima J, Maia J 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

18. Halász P, Elger C, Guekht A, et al. Long-term efficacy and safety of eslicarbazepine acetate: Results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy.  Epilepsia, 51(10):1963-1969, 2010

19. Gabbai A, Ben-Menachem E, Maia J, et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate (ESL): results of a one-year open-label extension of study BIA-2093- 302 (Abstract No. 3.208). Epilepsia. 2008;49(Suppl. 7):432-3

20. Lopes-Lima J, Gil-Nagel A, Maia J, et al. Long-term treatment of partial epilepsy with eslicarbazepine acetate (ESL): results of a one-year open-label extension of study BIA-2093-303 (Abstract No. 3.227). Epilepsia. 2008;49(Suppl. 7):441-2.

 

Date of preparation: September 2012

Job code: Zebinix-UK2255

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Some people worry that OpenStack is more flash then substance; however, for many customers this could not be farther from the truth. No other technology equalizes the playing field between vendors while giving your internal teams better access than ever to infrastructure when they need it. In his session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will talk through some real-world OpenStack deployments and look into the ways this can benefit customers of all sizes....
Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infrastructure through automation. Ayehu solutions have been deployed by major enterprises worldwide, and currently, support thousands of IT processes across the globe. The company has offices in New York, California, and Isr...
"A lot of times people will come to us and have a very diverse set of requirements or very customized need and we'll help them to implement it in a fashion that you can't just buy off of the shelf," explained Nick Rose, CTO of Enzu, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Zerto exhibited at SYS-CON's 18th International Cloud Expo®, which took place at the Javits Center in New York City, NY, in June 2016. Zerto is committed to keeping enterprise and cloud IT running 24/7 by providing innovative, simple, reliable and scalable business continuity software solutions. Through the Zerto Cloud Continuity Platform™, organizations can seamlessly move and protect virtualized workloads between public, private and hybrid clouds. The company’s flagship product, Zerto Virtual...
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said "No to LUNs." With Tintri they manage only virtual machines, in a fraction of the footprint and at far lower cost than conventional storage. Tintri offers the choice of all-flash or hybrid-flash platform, converged or stand-alone structure and any hypervisor. Rather than obsess with storage, leaders focus on the business app...
Addteq is one of the top 10 Platinum Atlassian Experts who specialize in DevOps, custom and continuous integration, automation, plugin development, and consulting for midsize and global firms. Addteq firmly believes that automation is essential for successful software releases. Addteq centers its products and services around this fundamentally unique approach to delivering complete software release management solutions. With a combination of Addteq's services and our extensive list of partners,...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it m...
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.