On the back of positive late-stage data, Eisai says it plans to submit its epilepsy drug Zonegran to European regulators as a first-line monotherapy for the neurological condition. Zonegran (zonisamide) is already licensed as adjunctive therapy in the treatment of partial seizures in adult epilepsy patients. However, the Japanese drugmaker says a new Phase III study showed the treatment is effective and well tolerated in newly-diagnosed epilepsy patients when used as monotherapy. The trial compared once-daily zonisamide with twice-daily controlled-release carbamazepine in 582 adults with newly-diagnosed partial epilepsy. The data met the criteria of noninferiority in terms of the proportion of patients who were seizure-free at six months: 79.4% of zonisamide-treated patients and 83.7% of those on carbamazepine.
