CHMP extends use of Zonegran (Eisai) as monotherapy for Epilepsy

May 2012-The CHMP has issued a positive opinion for extending the use of once-daily Zonegran (zonisamide), from Eisai, as monotherapy for the treatment of partial seizures (with or without secondary generalisation) in adults with newly diagnosed Epilepsy. For patients with newly diagnosed epilepsy, monotherapy is the preferred option for managing their condition as this reduces the potential for adverse drug interactions. The efficacy and safety of Zonegran as monotherapy has been demonstrated in a double-blind, randomised, multicentre study of 583 adult newly diagnosed partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy. Zonegran demonstrated high response rates for achieving seizure freedom in newly diagnosed patients with epilepsy, similar to controlled release carbamazepine. In the majority of patients, seizure freedom was achieved at the target dose of 300 mg. Zonegran was well tolerated and no apparent safety concerns of one year treatment at doses ranging from 300 to 500 mg/day were identified.