With this license extension application, the company is seeking marketing approval from the EMA for Zonegran as a monotherapy for patients suffering from epilepsy with partial seizures, with and without secondary generalization.
The submission of the application was done on the basis of a multicenter, double-blind, randomized study comparing daily zonisamide with twice-daily controlled release carbamazepine as monotherapy.
The study involved around 583 adult patients with newly diagnosed partial-onset epilepsy.
The results of the trial suggested that zonisamide was effective and well tolerated when used as a monotherapy in newly diagnosed epilepsy patients.