Of the 2058 patients included in Euro-Esli (mean age 44.0 years; 52.1% male), information on ESL dosing was known for 1920 patients. Among these patients, 12 Dic. (91.1%) - were treated with ESL less than or equal to1200 mg/day and 171 (8.9%) were treated with ESL >1200 mg/day. The number of prior antiepileptic drugs used was significantly lower in patients treated with ESL less than or equal to1200 vs >1200 mg/day (median, 3 vs 4; mean, 4 vs 5; p<0.001; Mann-Whitney test). At all timepoints, responder and seizure freedom rates were significantly higher in patients treated with ESL less than or equal to1200 mg/day than in those treated with ESL >1200 mg/day. The overall incidence of AEs was significantly higher in patients treated with ESL less than or equal to1200 mg/day vs >1200 mg/day (34.8% vs 22.8%; 2=9.91; p=0.002; Chi-squared test). Similarly, the rate of ESL discontinuation due to AEs was significantly higher in patients treated with ESL less than or equal to1200 mg/day vs >1200 mg/day (14.7% vs 6.1%; 2=9.27; p=0.002; Chi-squared test).
About Zebinix(R) (eslicarbazepine acetate)
Eslicarbazepine acetate is a voltage-gated sodium channel blocker, which selectively targets the slow inactivated state of the sodium ion channel.[8] The efficacy of eslicarbazepine acetate was demonstrated in an initial proof-of-concept phase II study[9] and three subsequent phase III randomised, placebo controlled studies in 1,049 people with refractory partial-onset seizures.[10],[11],[12]
Eslicarbazepine acetate is currently marketed in Europe and Russia by Bial 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.
About Bial
Founded in 1924, Bial's mission is to discover, develop, and provide therapeutic solutions within the area of health. In recent decades, Bial has strategically focused on quality, innovation, and internationalisation.
Bial is strongly committed to therapeutic innovation, investing more than 20 per cent of its turnover in Research and Development (R&D) every year.
Bial has established an ambitious R&D program centered on the neurosciences and cardiovascular system. The company expects to introduce more new medicines to the market in the next years, strengthening its international presence based in its own innovative medicines, and accomplishing the company's purpose of "Caring for your Health."
For more information about Bial, please visit www.bial.com [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 www.eisai.com [http://www.eisai.com ].
References
1. Peltola J, McMurray R, Villanueva V. (2017) Efficacy, safety and tolerability of eslicarbazepine acetate in patients transitioning from carbamazepine or oxcarbazepine in everyday clinical practice. American Epilepsy Society Annual Meeting (AES) 2017; Washington, US. Abst. 1.319.
2. Villanueva V, McMurray R. (2017) Effectiveness, safety and tolerability of eslicarbazepine acetate at doses >1200 mg/day versus less than or equal to1200 mg/day: real-world evidence from the Euro-Esli study. American Epilepsy Society Annual Meeting (AES) 2017; Washington, US. Abst. 1.318.
3. McMurray R, Villanueva V, Delanty R. (2017) Real-world data on the effectiveness, safety and tolerability of eslicarbazepine acetate monotherapy in clinical practice. American Epilepsy Society Annual Meeting (AES) 2017; Washington, US. Abst. 2.313.
4. Saxena S, et al. (2017) Defeating epilepsy: A global public health commitment. Epilepsia Open. 2 (2), 153-155.
5. Fisher, R.S., et al. (2014) ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia. 55(4), 475-482.
6. Laxer D, et al. (2014) The consequences of refractory epilepsy and its treatment. Epilepsy & Behaviour. 37, 59-70.
7. Eisai. (2017) Zebinix(R) (eslicarbazepine acetate) Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... 88/WC500047225.pdf. [Accessed October 2017].
8. Hebeisen S, et al. (2015) Eslicarbazepine and the enhancement of slow inactivation of voltage-gated sodium channels: A comparison with carbamazepine, oxcarbazepine and lacosamide. Neuropharmacology. 89, 122-135
9. Elger C, et al. (2007) Eslicarbazepine acetate: A double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia. 48, 497-504.
10. Elger C, et al. (2009) 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. 50, 454-63.
11. Ben-Menachem E, et al. (2010) Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Research. 89(2-3), 278-85.
12. Gil-Nagel A, et al. (2009) Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurologica Scandinavica. 120, 281-87.
December 2017 Zebinix-EU0153
CONTACT: Media Enquiries: Bial, Susana Vasconcelos,Susana.vasconcelos@bial.com; Eisai, Helena Symeou, +44 7505 309 895,Helena_Symeou@eisai.net; Tonic Life Communications, Chrissie Hannah, +44777 253 4646, chrissie.Hannah@toniclc.com
