Eisai presented the results of two Phase III studies for anti-epilepsy treatment Zonegran (zonisamide) at the 29th International Epilepsy Congress in Rome, Italy, this weekend.
The European Medicines Agency has accepted for review Eisai’s license extension application for zonisamide as a monotherapy for newly diagnosed epilepsy patients with partial seizures, with or without secondary generalisation.
The zonisamide in monotherapy study and the CATZ study, zonisamide in paediatric patients, were presented for the first time at the Congress, which ran from August 28 until its conclusion on September 1.
In addition, posters highlighting results from the new phase IV studies ZADE, OZONE and ZENIT, on the impact of zonisamide on everyday clinical practice in Europe, were also presented.
The double-blind, randomised, multicentre monotherapy study set out to compare the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy in 583 adults with newly diagnosed partial epilepsy.
The double-blind, randomised, multicentre, placebo-controlled CATZ study set out to assess the efficacy and safety/tolerability of adjunctive zonisamide in 207 paediatric patients (six to 17 years) with partial-onset seizures who were on one or two anti-epileptic drugs.
The ZADE study evaluated efficacy, tolerability and quality of life effects of adjunctive zonisamide in patients with partial seizures treated in everyday clinical practice in Germany and Austria.
The OZONE study evaluated the efficacy and tolerability of zonisamide in current medical practice in patients aged ≥ 18 years with focal epilepsy treated by neurologists in hospital or private offices in France.
The ZENIT study evaluated a range of outcomes in epilepsy patients being prescribed zonisamide in everyday clinical practice in Denmark, Finland, Norway and Sweden.
“These study results highlight our commitment to developing and delivering epilepsy treatments that really help improve the lives of people with epilepsy,” said Dr Bettina Bauer, Head of EU Epilepsy Business Unit at Eisai Europe.
“Zonisamide is just one example of Eisai’s strong epilepsy product portfolio”.