lunes, 18 de abril de 2016

Bial and Eisai announce new data that once-daily Zebinix® (eslicarbazepine acetate) monotherapy is effective and well tolerated according to first data presented at the American Academy of Neurology (AAN) annual meeting


Positive results from a Bial sponsored Phase III study in adult patients with newly diagnosed partial-onset seizures show that treatment with once daily Zebinix® (eslicarbazepine acetate) monotherapy is as effective as twice daily controlled-release carbamazepine, a standard of care, and is well-tolerated. Eslicarbazepine acetate is currently indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation.   
Efficacy analysis from this study shows seizure freedom rates with eslicarbazepine acetate are similar to that of controlled-release carbamazepine ie; (71.1% versus 75.6%) in 785 eligible patients at ≥6 months at the last evaluated dose (average risk difference -4.28%, 95%CI -10.3, 1.74%).  The one-year seizure-free rate at the last evaluated dose was 64.7% in the eslicarbazepine acetate group and 70.3% in the controlled-release carbamazepine group (average risk difference: -5.46%; 95%CI: -11.88, 0.97%).

A safety analysis in 813 patients shows that once-daily eslicarbazepine acetate is well tolerated and side effects are mild to moderate. Incidence rates of treatment emergent adverse events (TEAEs) were similar but slightly lower in patients receiving eslicarbazepine acetate versus patients receiving controlled-release carbamazepine (77.8% vs 80.1% respectively). Possibly-related TEAEs for eslicarbazepine acetate were 43.6% compared with 51.5% for controlled release carbamazepine.  Serious treatment-related TEAEs in eslicarbazepine acetate treated patients versus patients treated with controlled release carbamazepine were 2.0% vs 2.7% and for TEAEs leading to withdrawal were 13.5% vs 18%.The most frequently reported possibly-related TEAEs for eslicarbazepine acetate were headache, dizziness, nausea, fatigue, and somnolence.

“According to these data the efficacy of eslicarbazepine acetate monotherapy is clear, as 71% of people are seizure-free for six consecutive months.  With a similar efficacy and safety profile to controlled-release carbamazepine we hope thateslicarbazepine acetate may be another potential treatment option for patients in the future,” comments Professor Eugen Trinka, Professor and Chair of the Department of Neurology, Paracelsus Medical University, Salzburg, Austria.

“This is the first time that data are presented for eslicarbazepine acetate as once daily monotherapy for the treatment of adult patients who have just been diagnosed with partial-onset seizures. This underscores Bial’s commitment to explore effective treatments for patients affected by epilepsy at all stages of their illness,” comments Patrício Soares-da-Silva, Head of Research & Development, Bial.

This pivotal Phase III study is a randomised, double-blind, parallel-group, active-controlled and non-inferiority study, investigating the efficacy and safety of once-daily eslicarbazepine acetate (800 to 1600 mg/daily) as monotherapy treatment for newly diagnosed adults (18 years and older) with partial-onset seizures in comparison with twice-daily controlled-release carbamazepine (400 to 1200 mg/daily).  The primary endpoint is the proportion of people seizure free for the entire 26-week evaluation period.  Secondary endpoints include the time to first seizure, a QOLIE-31 quality of life assessment, and safety. The study examines data from 900 (815 available for efficacy and 813 available for safety analyses) newly diagnosed people (aged 18 and over) with epilepsy who experience partial-onset seizures, to evaluate eslicarbazepine acetate as a single treatment option.

The continued development of eslicarbazepine acetate underscores Bial and Eisai’s commitment in optimizing the treatment care of patients with epilepsy. Eslicarbazepine acetate is already 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®