Bial's Zebinix meets Phase III endpoints in new epilepsy study

7 December 2015

Bial Portela, Portugal’s largest drugmaker, has released positive results for a pivotal Phase III non-inferiority study comparing the efficacy and safety of eslicarbazepine acetate (ESL; trade name Zebinix) to controlled release carbamazepine (CBZ-CR) as monotherapy in newly-diagnosed adult patients with partial-onset seizures (POS).

This pivotal Phase III trial was a randomized, double-blind, parallel-group, active-controlled and non-inferiority study, investigating the efficacy and safety of once-daily ESL (800 to 1,600mg/daily) as monotherapy treatment for newly diagnosed adults with partial-onset seizures in comparison with twice-daily CBZ-CR (400 to 1,200mg/daily).

To file for expanded indication

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