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GEN News Highlights : Jul 12, 2011

Eisai Plans EU Filing for Epilepsy Drug as Monotherapy Following Positive Phase III Data

Study confirmed noninferiority of once-daily zonisamide compared with carbamazepine.

Eisai’s European subsidiary says it plans to file for EU approval of the antiseizure drug Zonegran® (zonisamide) as monotherapy in newly diagnosed epilepsy patients, on the back of positive data from a Phase III trial. The drug is already licensed as adjunctive therapy in the treatment of partial seizures in adult epilepsy patients.

The Phase III monotherapy study (designated E2090-E044-310) compared the efficacy and safety of once-daily zonisamide with twice-daily controlled-release carbamazepine in 582 adult patients with newly diagnosed partial epilepsy. Results confirmed the noninferiority of zonisamide in terms of the proportion of patients who were seizure-free at six months: 79.4% of zonisamide-treated patients and 83.7% of carbamazepine-treated patients. Twelve-month results were consistent with those at six months.

Zonisamide is currently being evaluated as a treatment for children with partial onset seizure who are treated with one or two other antiepileptic drugs.