Large Pan-European Pooled Analyses of Zebinix® (eslicarbazepine acetate) Real-World Data to Assess Use for Partial Epilepsy in Clinical Practice

PORTO, Portugal and HATFIELD, England, September 8, 2016 /PRNewswire/ --

FOR EMEA MEDIA ONLY - NOT FOR SWISS/AUSTRIAN/CZECH REPUBLIC JOURNALISTS   

Further insights into seizure control and safety profile of epilepsy drug in the treatment of newly diagnosed partial onset (focal) seizures in adults

BIAL and Eisai announce the methodology of a planned, large, pooled analyses of real-world efficacy and safety data for adjunctive once-daily Zebinix^® (eslicarbazepine acetate) to be presented for the first time at the 12^th European Congress on Epileptology (ECE) 2016, Prague, Czech Republic.^[1]

Once-daily eslicarbazepine acetate is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.^[2]

Abstract #P578 - Mc Murray R et al^[1] - 12 September 13:00-14:30

The study will comprise pooled analysis in over 1,500 adult patients from databases across Europe to provide further information on dosing patterns, combinations, and response to treatment with once-daily eslicarbazepine acetate. This large pooled analyses of patient-level data will provide additional information on the effectiveness and tolerability of eslicarbazepine acetate in routine clinical practice, thereby complementing evidence from clinical trials.

Abstract #0002 - Ben-Menachem et al^[3] - 14 September 11.30-13.00 

Abstract #P615 - E Trinka E et al^[4] - 14 September 13:00-14:30 

Further data at this year's ECE includes outcomes from an investigational Phase III study^[3],[4] in 785 eligible patients for eslicarbazepine acetate in a monotherapy setting compared with twice-daily controlled-release (CR) carbamazepine. Seizure freedom rates with eslicarbazepine acetate were 71.1% (n=388) and 75.6% (n=397) with carbamazepine CR at ≥6 months (average risk difference -4.28%, 95%CI -10.3, 1.74%).^[3],[4]   Patients experiencing at least one treatment emergent adverse event were similar between eslicarbazepine acetate and carbamazepine CR (75.3% vs 77.7% respectively).^[3],[4]

Abstract #0034 - Villanueva V et al^[5] - 13 September 11:30-13:00  

Results from a one-year retrospective observational study, EARLY-ESLI, in 253 patients aged ≥18 with partial-onset seizures receiving eslicarbazepine acetate after first-line monotherapy failure will be presented. During follow-up 31.6% reported adverse events, and 3.6% discontinued treatment due to AEs.^[5] At 12 months, the retention rate was 92.9%, 62.3% of patients were seizure free, 37.3% were seizure free for one year, 82.5% were responders, and 5.6% did worse. The main side-effects were somnolence (8.7%), dizziness (5.1%), and hyponatremia (3.5%; n=9).^[5] A total 127 patients (50.2%) converted (withdrew) to monotherapy for at least six months.

"These new data confirm our commitment to continue to develop treatments that help people with epilepsy to get on with their lives through seizure control, tolerability, and convenience. The planned real-world study will help improve the knowledge and understanding around the use of eslicarbazepine acetate in routine clinical practice," states Patrício Soares-da-Silva, Head of Research & Development, BIAL

Eslicarbazepine acetate is 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^®

***Exalief^® is the trade name for eslicarbazepine acetate in Russia

   
    Abstract Number
    Timing of presentation     Abstract details

    Eslicarbazepine acetate    Effectiveness of eslicarbazepine acetate as
    Abstract number: #P578     adjunctive therapy for partial epilepsy in clinical
    Poster Session             practice: design of a European pooled analysis of
    Pharmacology / AEDs 3      real-world data
    Monday 12 September        Rob McMurray, Camilla Karlsson, Rui Sousa, Vicente
    13.00 - 14.30              Villanueva
    Poster Area (Forum Hall   
    Foyer)
               
    Abstract number: #0034     EARLY-ESLI study: Efficacy, tolerability and
    Platform Session 6         conversion to monotherapy with eslicarbazepine
    Antiepileptic Drugs 2      acetate after first monotherapy failure
    Tuesday 13 September       V Villanueva, A Gómez, M Garcés, P Bermejo, J
    11:30-13:00                Montoya, M Toledo, FJ López-González, X Rodriguez, D
    Forum Hall                 Campos, P Martínez, P Giner, J Zurita, J
                               Rodríguez-Uranga, J Ojeda, JA Mauri, J Ruiz-Giménez,
                               JJ Poza, A Massot, M Bonet
                    
    Abstract number: #0002     Efficacy of eslicarbazepine acetate versus
    Platform Session 13        controlled-release carbamazepine as monotherapy in
    Antiepileptic Drugs 3      patients with newly diagnosed partial-onset seizures
    Wednesday 14 September     E Ben-Menachem, E. Trinka, P Kowacs, C Elger, J
    11:30-13:00                Moreira, R Pinto, F Ikedo, A Pereira, JF Rocha,
    Forum Hall                 P Soares-da-Silva

    Abstract number: #P615     Safety and tolerability of eslicarbazepine acetate as
    Poster Session             monotherapy in patients with newly diagnosed
    Pharmacology / AEDs 8      partial-onset seizures
    Wednesday 14 September     E Trinka, E Ben-Menachem, P Kowacs, C Elger, J
    13:00-14:30                Moreira, R Pinto, F Ikedo, A Pereira, JF Rocha,
    Location                   P Soares-da-Silva
    Poster Area (Forum Hall   
    Foyer)                    

Notes to Editors 

About Zebinix^® (eslicarbazepine acetate)

Eslicarbazepine acetate is currently marketed in Europe and Russia by BIAL-Portela & Cª, S.A and by BIAL´s licensee, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd. under the trade name Zebinix^® or Exalief^®. In the United States and Canada eslicarbazepine acetate (tradename Aptiom^®) is marketed by Sunovion Pharmaceuticals Inc., under an exclusive license from BIAL.

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel (which have been implicated in the pathogenesis of epilepsy), preventing its return to the active state, and thereby reduces repetitive neuronal firing.^[6] Further, eslicarbazepine acetate does not inhibit potassium efflux, which may reduce the potential for repetitive neuronal firings.^[7] 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 1,049 people with refractory partial onset seizures.^{[9],[10],[11]}

About BIAL  

Founded in 1924, BIAL is an international pharmaceutical company with the mission to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has focused on quality, innovation and internationalisation.

Being the partner of choice for many companies, BIAL is strongly committed to therapeutic innovation, investing more than 20% of its turnover in Research and Development (R&D) every year.

BIAL has established an ambitious R&D program centred on the central nervous, cardiovascular system and allergy 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.

The company expects to introduce more new medicines and vaccines to the market in the next years, strengthening its position worldwide and accomplishing the company's purpose of "Caring for your Health".

For more information about BIAL, please visit http://www.bial.com .

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

References 

1.        McMurray R, et al. Effectiveness of eslicarbazepine acetate as adjunctive therapy for partial epilepsy in clinical practice: design of a European pooled analysis of real-world data; European Congress on Epileptology 2016: Abstract #P578 

2.     Zebinix® (eslicarbazepine acetate) SPC - Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000988/WC500047225.pdf  [updated 19th May 2016]. Accessed September 2016 

3.     Ben-Menachem E, et al. Efficacy of eslicarbazepine acetate versus controlled-release carbamazepine as monotherapy in patients with newly diagnosed partial-onset seizures; European Congress on Epileptology 2016: Abstract #0002 

4.     Trinka E, et al. Safety and tolerability of eslicarbazepine acetate as monotherapy in patients with newly diagnosed partial-onset seizures; European Congress on Epileptology 2016: Abstract #P615 

5.     Villanueva V, et al. EARLY-ESLI study: Efficacy, tolerability and conversion to monotherapy with eslicarbazepine acetate after first monotherapy failure: Abstract #0034 

6.     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; 89:122-35 

7.     Soares-da-Silva P, et al. Eslicarbazepine acetate for the treatment of focal epilepsy: an update on its proposed mechanisms of action. Pharmacol Res Perspect. 2015; 3:e00124 

8.     Elger C, et al. Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia 2007; 48:497-504 

9.     Elger C, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: A randomised, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50:454-63 

10.     Ben-Menachem E, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-3):278-85 

11.     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; 120:281-87