Phase III data with Zebinix (eslicarbazepine acetate) shows effectiveness and safety in epilepsy- Bial

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. 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 longer than 6 months at the last evaluated dose. 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.

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.

Comment: Eslicarbazepine acetate is currently indicated in Europe as adjunctive therapy in adults with partial onset seizures, with or without secondary generalisation. With more convenient dosing and a purported improved safety profile over Trileptal and Tegretol, Zebinix /Aption is forecast to become the best-selling pipeline antiepileptic drug. Factoring monotherapy approval and first-line use, epilepsy-specific sales are forecast to top $400 million across the seven major markets by 2019.