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

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(R) (eslicarbazepine acetate) to be presented for the first time at the 12th 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 greater than or equal to6 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 greater than or equal to18 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(R)

***Exalief(R) 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(R) (eslicarbazepine acetate)

Eslicarbazepine acetate is currently marketed in Europe and Russia by BIAL-Portela & C (a), S.A and by BIAL's licensee, Eisai Europe Limited, a European subsidiary of Eisai Co., Ltd. under the trade name Zebinix(R) or Exalief(R). In the United States and Canada eslicarbazepine acetate (tradename Aptiom(R)) 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.

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