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.

Previous articleGilead Grants New and Expanded Generics Licenses for HIV Drugs to Indian Firms
Next articleIpsen Renews Salk Institute Partnership and Signs Cancer Research Collaboration with IGR