European Medicines Agency (EMA) Accepts Bial's Submission for Once-daily Epilepsy Treatment Zebinix® (eslicarbazepine ac

1. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders 2010 (22 July); CHMP/EWP/566/98 Rev.2/Corr

2. Zebinix(R) Summary of Product Characteristics http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... (accessed April 2015)

3. Food and Drug Administration, Highlights of Prescribing Information https://www.accessdata.fda.gov/drugsatfd... (accessed May 2016)

4. Trinka E, et al. Efficacy of eslicarbazepine acetate versus controlled-release carbamazepine as monotherapy in patients with newly diagnosed partial-onset seizures. Presented at AAN 2016; abstract 001

5. Kowacs P, et al. Safety and tolerability of eslicarbazepine acetate as monotherapy in patients with newly diagnosed partial-onset seizures. Presented at AAN 2016; abstract 002

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. European Medicines Agency, Zebinix eslicarbazepine acetate, How does it work? http://www.ema.europa.eu/ema/index.jsp?c... (accessed April 2016)

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; 120:281-7 Date of preparation: May 2016

Job code: Zebinix-UK 2402

CONTACT: Media Enquiries: BIAL, Susana Vasconcelos, +351 229866100 / +351229866148, susana.vasconcelos@bial.com ; Eisai, Cressida Robson / BenSpeller, +44(0)7908 314 155 / +44(0)7908 409 416, cressida_Robson@eisai.net/ ben_Speller@eisai.net ; Tonic Life Communications, Madeleine Nelson /Elisabeth Neal, +44 (0) 77 9247 3840 / +44 (0) 78 9695 4865,madeleine.nelson@toniclc.com / elisabeth.neal@toniclc.com