HATFIELD, England, August 29, 2011 /PRNewswire/ --
25 abstracts accepted for presentation
Eisai and BIAL announced today that 25 abstracts, highlighting an extensive development programme for Zebinix® (eslicarbazepine acetate), have been accepted for presentation during the 29th International Epilepsy Congress, taking place in Rome from 28 August until 1 September, 2011. The presentations evaluate the use of eslicarbazepine acetate as monotherapy, its efficacy and safety in children with partial-onset seizures, its cognitive effects when used as an add-on therapy in children and its potential for use in elderly patients with partial-onset seizures*. Zebinix® is approved in Europe as adjunctive therapy for use in adults with partial-onset seizures with or without secondary generalisation. The ongoing development programme is aimed at expanding treatment options for patients with epilepsy.
"We know from previous clinical trials and ongoing clinical practice that eslicarbazepine acetate is an effective add-on therapy for adults with partial-onset seizures, with or without secondary generalisation that is easy to titrate, is well tolerated and offers once-daily dosing. These clinical trial results together with the extensive clinical trial programme highlight the potential that Zebinix® has to improve seizure control and expand its use in epilepsy," said Professor Eugen Trinka, Universitätsklinik für Neurologie, Universität Salzburg, Austria.
A world-wide clinical study, involving 170 centres in 30 countries is ongoing, investigating the efficacy and safety of eslicarbazepine acetate as a first-line monotherapy in 900 newly diagnosed adults, in comparison to controlled-release carbamazepine. This study is in full compliance with current European guidance, and could be a pivotal development in extending treatment options for patients with epilepsy.
"These clinical trial results and planned studies reinforce Eisai and BIAL's commitment to developing and delivering new treatments to help improve the lives of people with epilepsy. We are proud of our involvement in this field and look forward to seeing the results from studies in monotherapy, children and the elderly," said Dr Bettina Bauer, Head of EU Epilepsy Business Unit, Eisai Europe.
Following the identification of eslicarbazepine acetate target doses in children, a trial is underway which aims to provide the first efficacy and safety data for eslicarbazepine acetate in the treatment of paediatric partial-onset seizures. As cognitive co-morbidity is of particular concern in children with epilepsy, due to the impact on learning and psychosocial interaction, a second paediatric study is being conducted in children and adolescents with refractory partial-onset seizures to assess the cognitive effects and safety of adjunctive eslicarbazepine acetate. Cognitive effects will be assessed using a validated cognitive test battery, and will be related to the developmental changes and disease progression occurring in the study population.
Epilepsy rates are higher in the elderly than in any other patient population; however, patients over 65 years of age are rarely included in large clinical trials due to the increased risk of side effects and the potential for altered pharmacokinetics. It has previously been shown that the pharmacokinetics of eslicarbazepine acetate are similar in both young and elderly healthy volunteers, suggesting that eslicarbazepine acetate may be a useful treatment option in this patient population. The current study aims to assess the effects of eslicarbazepine acetate on seizure frequency and safety when used as adjunctive treatment in elderly patients.
In addition to studies in specific patient populations, the use of eslicarbazepine acetate in a broader adult population has also being evaluated and presented during the IEC in Rome 2011. The results of a post-hoc analysis of the efficacy and safety in patients, with partial-onset seizures, revealed that patients refractory to ongoing treatment with carbamazepine respond well to adjunctive eslicarbazepine acetate.
It is anticipated that the new clinical trials will be completed between 2012 and 2013 and the results will help guide future treatment options for adult patients with epilepsy, as well as for specific paediatric and elderly populations.
Notes to Editors
A media briefing will be held at the International Epilepsy Congress at 16:00 - 17:30 on 29 August 2011. Please contact Benjamyn Tan if you would like to attend or require more information (firstname.lastname@example.org).
Zebinix® is the EU trade name for eslicarbazepine acetate.
The following eslicarbazepine acetate abstracts submitted by BIAL are accepted for presentation at this year's International Epilepsy Congress meeting:
Reference Abstract name/author Platform session 4 Pharmacotherapy An evaluation of efficacy and safety of Reference: 021 adjunctive eslicarbazepine acetate in three double blind clinical studies on patients with Date: 30 August partial-onset seizures unsatisfactorily 2011 treated with carbamazepine Time:14.00-15.30 Halasz P Poster session: Drug therapy I In healthy subjects, concomitant use of carbamazepine with eslicarbazepine acetate can Reference: p346 decrease exposure to eslicarbazepine: lack of pharmacokinetic effects of eslicarbazepine Date: 30 August acetate on carbamazepine and its 10,11-epoxide 2011 metabolite confirms findings from clinical phase III studies Time: 13.00-14.00 Perucca E Poster session: Drug therapy I Reference: p339 Incidence of adverse events in relation to starting-dose and titration regimen of Date: 30 August eslicarbazepine acetate as add-on treatment in 2011 patients with partial-onset seizures Time:13.00-14.00 Guekht A Poster session: Drug therapy I Reference: p340 Steady-state pharmacokinetics of Date: 30 August eslicarbazepine acetate: integrated pool 2011 analyses from three double-blind Phase III clinical studies Time: 13.00-14.00 Falcao A Poster session: Drug therapy I Reference: p341 To what extent can eslicarbazepine acetate Date: 30 August influence the plasma levels of combined 2011 antiepileptic drugs? An evaluation based on three double-blind Phase III clinical studies Time: 13.00-14.00 Bialer M Poster session: Drug therapy I Reference: p342 Methods used to evaluate cognitive effects of Date: 30 August eslicarbazepine acetate add-on therapy in 2011 epileptic children of age 6-16: the design of a placebo-controlled clinical trial Time: 13.00-14.00 Capovilla G Poster session: Drug therapy I The design of a double-dummy, Reference: p343 active-controlled, multi-national Phase-III non-inferiority trial in 900 patients with Date: 30 August partial-onset seizures: eslicarbazepine 2011 acetate versus controlled release carbamazepine in monotherapy Time: 13.00-14.00 Trinka E Poster session: Drug therapy I Reference: p344 Date: 30 August The design of a phase III clinical study of 2011 eslicarbazepine acetate in elderly patients with partial-onset seizures in epilepsy Time: 13.00-14.00 Nunes T Poster session: Drug therapy I Reference: p345 The effect of eslicarbazepine acetate 800 mg Date: 30 August and 1200 mg once-daily on the pharmacokinetics 2011 of a combined oral contraceptive in healthy female volunteers Time: 13.00-14.00 Vaz-da-Silva M Poster session: drug therapy I Reference: p338 Date 30 August The metabolism and elimination pathway through 2011 glucuronidation of eslicarbazepine acetate and its metabolites Time: 13.00-14.00 Loureiro Al Poster session: Drug therapy V Reference: p802 A clinical study method used to evaluate the efficacy and safety of novel antiepileptic Date: 31 August drug eslicarbazepine acetate in epileptic 2011 children with partial-onset seizures Time:13.00-14.30 Pinto R Poster session: drug therapy IX Reference: p849 Date: 31 August Effects of eslicarbazepine acetate in the 2011 amygdala kindling model of temporal lobe epilepsy Time: 13.00-14.30 Soerensen J Post session: drug therapy IX Reference: p850 Date: 31 August Effects of eslicarbazepine acetate and its 2011 metabolites in the corneal kindling mice model of epilepsy Time: 13.00-14.30 Pekcec A Poster session: drug therapy IX Reference: p851 Date: 31 August Inhibitory effects of eslicarbazepine acetate 2011 and its metabolites against neuronal voltage-gated sodium channels Time: 13.00-14.30 Hebeisen S Poster session: drug therapy IX Reference: p852 Date: 31 August Effects of eslicarbazepine, R-licarbazepine 2011 and carbamazepine on NMDA and AMPA receptor-mediated currents Time: 13.00-14.30 Bulling A Poster session: drug therapy IX Reference: p858 The effects of eslicarbazepine, Date: 31 August R-licarbazepine, oxcarbazepine and 2011 carbamazepine on ion transmission through Cav3.2 channels Time: 13.00-14.30 Brady K Poster session: drug therapy IX Reference: p853 Eslicarbazepine and R-licarbazepine do not Date: 31 August have effects on ion transmission through 2011 alpha1, alpha2, alpha3 and alpha5 GABA channels Time: 13.00-14.30 Bonifacio MJ Poster session: drug therapy IX Reference: p854 Date: 31 August The effects of eslicarbazepine, 2011 R-licarbazepine and carbamazepine on ion transmission through Kv7.2 channels Time: 13.00-14.30 Soares da Silva P Poster session: drug therapy VI Reference: p815 A validated chiral liquid-chromatography tandem mass-spectrometry (LC-MS/MS) method for Date: 31 August the separation and quantification of 2011 eslicarbazepine acetate and its metabolites in human plasma Time: 13.00-14.30 Fernandes-Lopes C Poster session: drug therapy IV Reference: p373 Effects of eslicarbazepine acetate, Date: 31 August eslicarbazepine, carbamazepine and 2011 oxcarbazepine in the maximal electroconvulsive shock test in the mice Time: 13.00-14.00 Pires N Poster session: drug therapy IV Reference: p374 Effects of eslicarbazepine acetate, Date: 31 August eslicarbazepine, carbamazepine and 2011 oxcarbazepine in the 6-Hz psychomotor seizure model in the mice Time: 13.00-14.00 Torrao L Poster session: drug therapy IV Reference: p375 Date: 31 August Effects of eslicarbazepine, R-licarbazepine, 2011 oxcarbazepine and carbamazepine on glycine GlyRalpha3 receptor-mediated inward currents Time: 13.00-14.00 Wright LC Poster session: drug therapy IV Reference: p376 Effects of eslicarbazepine acetate on acute Date: 31 August and chronic Latrunculin A-induced seizures and 2011 extracellular amino acid levels in the mouse hippocampus Time: 13.00-14.00 Sierra-Paredes G Poster session: drug therapy IX The metabolic profile of patients with Reference: p848 epilepsy treated with eslicarbazepine acetate: integrated analyses of plasma lipid and Date: 31 August glucose parameters, and distribution of 2011 related adverse events in placebo-controlled phase III clinical studies Time: 13.00-14.30 Lopes-Lima J Poster session: Drug Therapy VII An integrated data analysis from three Reference: p832 placebo-controlled clinical studies on over-read electrocardiograms of epileptic Date: 31 August patients treated with eslicarbazepine acetate: 2011 are there any effects on cardiac impulse transmission? Time: 13.00-14.30 Gil-Nagel A
About Zebinix® (eslicarbazepine acetate)
Zebinix® is indicated as adjunctive therapy for adults with partial-onset seizures with or without secondary generalisation. Zebinix® is a once-daily, voltage-gated sodium channel blocker.[1,3] It specifically targets the inactivated state of the ion channel, preventing its return to the active state, and thereby reduces repetitive neuronal firing.[3,4] The efficacy of Zebinix® has been demonstrated in three randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.[3,4,5] Zebinix® also significantly improved patient's health related quality of life (HRQoL) as measured by the QOLIE-31 score during a one year open label extension of the above three studies.[6,7,8,9,10] Zebinix® is given orally once-daily.
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 and CEO: António Portela, "BIAL"), which gave Eisai Europe Limited rights to sell BIAL's anti-epileptic drug Zebinix®(eslicarbazepine acetate) in various European countries**.
** Eisai has rights to sell the product in 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, Sweden, Switzerland, Turkey, Ukraine and United Kingdom. In Spain, Eisai co-promotes the product with BIAL from launch.
Eisai 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 anti-epileptic drugs is a major strategic area for Eisai.
Eisai currently has three marketed treatments in Europe including:
- Zonegran® (zonisamide) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalization. (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 generalization. (Zebinix® is under license from BIAL)
- Inovelon® (rufinamide) for adjunctive treatment, 4 years and older of seizures associated with Lennox-Gastaut Syndrome.
Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its 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, multiple sclerosis, neuropathic pain, epilepsy, depression
- Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
- Vascular/immunological reaction including: acute coronary syndrome, atherothrombotic disease, severe sepsis, rheumatoid arthritis, psoriasis, Crohn's disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ 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, Hungary, Slovakia and the Netherlands.
For further information please visit our web site http://www.eisai.com
Founded in 1924, BIAL is an international pharmaceutical group with products available in more than 40 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 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 percent 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
* The term 'partial-onset seizure (POS) with or without secondary generalisation' in the indication section of Zebinix® summary of product characteristics (SPC) corresponds to 'focal onset seizures' defined in the report of the ILAE commission on classification and terminology, 2005-2009 as a part of the revised terminology and concepts for organization of seizures and epilepsies. Berg AT et al. (2010) Revised terminology and concepts for organization of seizures and epilepsies: Report of the ILAE Commission on Classification and Terminology, 2005-2009. Epilepsia 51 (4): 676-685.
1. Zebinix SPC (last updated January 2011): Available from: http://www.medicines.org.uk/emc/medicine/22376/SPC/ [http://www.medicines.org.uk/emc/medicine/22376/SPC ]
2. Halasz P, Ben-Menachem E, Gil-Nagel, et al. An evaluation of efficacy and safety of adjunctive eslicarbazepine acetate in three double-blind clinical studies on patients with partial-onset seizures unsatisfactorily treated with carbamazepine. Presented at the International Epilepsy Congress Tuesday 30 August 2011 (Abstract Number 428/Ref 021.
3. 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.
4. Ben-Menachem E, Gabbai A, Hufnagel A, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy; Epilepsy Research 2010;89:278-285.
5. Gil-Nagel A et al. Efficacy & Safety of 800 mg and 1200 mg eslicarbazepine acetete as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand 2009; 120:281-287
6. Cramer J, Elger C, Halász P et al. Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-301 study (Abstract No. 3.197). Epilepsia. 2008;49(Suppl. 7):426-
7. Soares-da-Silva P, Martins-da-Silva A, Gabbai AA et al. Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-302 study (Abstract No. 3.254). Epilepsia. 2008;49(7):455-6.
8. Pereira H, Lopes-Lima J, Gil-Nagel A et al. Assessment of Quality-of-Life and Depressive Symptoms During Long-Term Treatment with Eslicarbazepine Acetate: BIA-2093-303 study (Abstract No. 3.240). Epilepsia. 2008;49(Suppl. 7):446-8.
9. Cramer J, Maia J, Almeida L, et al. Quality-of-life improvement during long-term treatment with eslicarbazepine acetate (Abstract No. T278). Epilepsia. 2009;50(Suppl. 4):124.
10. Hodoba D, Czlonkowska A, Cramer J, et al. Depressive symptoms improvement during long-term treatment with eslicarbazepine acetate (Abstract No. T286). Epilepsia. 2009;50(Suppl. 4):126.
SOURCE Eisai Europe Limited