Publicado 04/12/2015 19:00
- Comunicado -

Bial Announces Zebinix® (eslicarbazepine acetate) Meets Primary Endpoint in Phase 3 Monotherapy Study for Patients With

Strongly committed to therapeutic innovation, BIAL's research and development (R&D) is focused on the central nervous system, cardiovascular system and allergic immunotherapy, and currently has several innovative programs under development, which it expects to bring to the market within the next years. The R&D projects of the company are also focused on the ongoing clinical development program of eslicarbazepine acetate, which is already commercialised in the United States and in several European markets. This program comprises studies designed to evaluate new therapeutic indications, such as adjuvant treatment in children and monotherapy.

Additionally Bial has completed the clinical development of opicapone, a compound to treat patients living with Parkinson's disease. This new drug is currently under evaluation by EMA.

For additional information on BIAL, please visit the company's web site at: http://www.bial.com

References: 

1) European Medicines Agency. Zebinix(R) (eslicarbazepine acetate): EU summary of

product characteristics. Available

from:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_...

(accessed 2 December 2015)

2) Sunovion Pharmaceuticals Inc. Aptiom(R) (eslicarbazepine acetate) tablets, for oral

use: US prescribing information. Available

from:http://www.accessdata.fda.gov/drugsatfda...

(accessed 2 December 2015).

3) Brodie MJ, Barry SJ, Bamagous GA et al. Patterns of treatment response in newly

diagnosed epilepsy. Neurology. 2012;15;78(20):1548-54.

4) Bialer M, Soares-da-Silva P. Pharmacokinetics and drug interactions of eslicarbazepine

acetate. Epilepsia 2012;53(6):935-46.

5) Soares-da-Silva P, Pires N, Bonifácio MJ, et al. Eslicarbazepine acetate for the

treatment of focal epilepsy: an update on its proposed mechanisms of action. Pharmacol

Res Perspect 2015; 3: e00124.

6) Elger C, Bialer M, Cramer J 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.

7) 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.

8) 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.

9) Lopes-Lima J, Gil-Nagel A, 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 Neurologica Scandinavica. 2009;120:281-287.

10) Sperling MR, Abou-Khalil B, Harvey J, et al. Eslicarbazepine acetate as adjunctive

therapy in patients with uncontrolled partial-onset seizures: Results of a phase III,

double-blind, randomized, placebo-controlled trial. Epilepsia. 2015;56:244-253.

11) 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. 2010;51(10):1963-1969.

12) Hufnagel A, Ben-Menachem E, Gabbai AA et al. Long-term safety and efficacy of

eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset

seizures in adults with epilepsy: results of a 1-year open-label extension study.

Epilepsy Research. 2013;103(2-3):262-9.

CONTACT: For any further questions please contact:Susana VasconcelosCommunication Managersusana.vasconcelos@bial.comRui SousaInternational Medical Affairs Managerrui.sousa@bial.comBial - Portela & Cª, S.A.+ 351 22 986 6100À Av. da Siderurgia Nacional4745-457 Coronado (S. Romão e S. Mamede)PORTUGAL

Contenido patrocinado