Eisai to file Zonegran as first-line epilepsy therapy in Europe on good trial results

Based on the positive results of a late-stage clinical trial, Japanese drug major Eisai’s (TYO: 4523) European subsidiary plans to seek European Medicines Agency approval for a first-line monotherapy indication for zonisamide in newly-diagnosed adults with epilepsy.

The company said that a new Phase III study (E2090-E044-310 Monotherapy Study) which showed that the anti-seizure treatment Zonegran (zonisamide/ZNS) is effective and well tolerated in newly diagnosed epilepsy patients when used as monotherapy.

Zonisamide is a second generation anti-epileptic drug with multiple mechanisms of action, with a chemical structure unrelated to other anti-seizure drugs, and with pharmacokinetic properties allowing once-daily dosing regimen. It was approved in Europe in 2005 as an adjunctive therapy in the treatment of partial seizures (with or without generalization) in adults with epilepsy.