Zebinix (eslicarbazepine acetate) filed with EMA as once-daily monotherapy for adults with newly diagnosed partial-onset epilepsy- Bial

The European Medicines Agency (EMA) has accepted Bial's application to review recent clinical trial data for Zebinix (eslicarbazepine acetate) for its use as a once-daily monotherapy in the treatment of adult patients with newly diagnosed partial-onset (focal) epilepsy. The submission was based on the results from a Bial sponsored Phase III study in adult patients with newly diagnosed partial-onset seizures which demonstrates that treatment with monotherapy is as effective as controlled-release carbamazepine, a standard of care, and is well-tolerated.

Zebinix, (eslicarbazepine acetate) is currently indicated in Europe as an adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation. In the US, eslicarbazepine acetate (Aptiom) is indicated for the treatment of partial-onset seizures as monotherapy or as an adjunctive therapy.