Bial and Eisai have announced the receipt of a positive opinion for Zebinix (eslicarbazepine acetate) from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly-diagnosed focal onset epilepsy.
Eslicarbazepine acetate can be used as a once-daily monotherapy and is currently indicated in Europe as adjunctive therapy in adults, adolescents and children aged above six years.
The CHMP’s decision is based on encouraging results from a Phase III study featuring 815 participants, which proved the efficacy of eslicarbazepine acetate as non-inferior to controlled-release carbamazepine in patients.
Eisai global neurology business unit EMEA vice-president Neil West said: "This positive opinion from the CHMP reinforces Eisai's commitment to researching and developing neurological treatment options that have the potential to help people manage their condition.
“We are pleased that this decision means patients in Europe who experience epilepsy will have a broader range of treatment options available."
The randomised, double-blind and active-controlled non-inferiority study compared once-daily eslicarbazepine acetate as treatment for newly diagnosed adults with focal-onset seizures to controlled-release carbamazepine, which was taken twice daily.
The side effects of eslicarbazepine acetate that were reported following a safety analysis of the same study were mostly of mild intensity, and consistent with the known safety profile.
Eslicarbazepine acetate is a voltage-gated sodium channel blocker that selectively targets the slow inactivated state of the sodium ion channel and prevents its return to the active state, thereby reducing repetitive neuronal firing.
The drug is currently marketed by Bial and its licensee Eisai Europe in Europe and Russia.