Zebinix (eslicarbazepine acetate) meets endpoint in phase III trial for partial-onset epilepsy- Bial

Bial has announced positive results for a pivotal phase III non-inferiority study comparing the efficacy and safety of Zebinix (eslicarbazepine acetate) to controlled release carbamazepine as monotherapy in newly diagnosed adult patients with partial-onset epilepsy seizures. The study met its primary endpoint, which was the proportion of seizure-free patients for six consecutive months under monotherapy treatment. The complete study results will disclosed shortly be at neurology and epilepsy conferences.

This pivotal phase III study was a randomised, double-blind, parallel-group, active-controlled and non-inferiority study, investigating the efficacy and safety of once-daily ESL (800 to 1600 mg/daily) as monotherapy treatment for newly diagnosed adults with partial-onset seizures in comparison with twice-daily CBZ-CR (400 to 1200 mg/daily). Based on these results, Bial intends to submit in the second quarter of 2016 a variation file to the European Medicines Agency, to expand the marketing authorization of eslicarbazepine acetate as monotherapy in adults with partial-onset seizures.

Comment: With more convenient dosing and a purported improved safety profile over Trileptal and Tegretol, Zebinix /Aption (eslicarbazepine acetate) 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.