New data supporting the safety and long-term efficacy of Eisai’s Zonegran when used as adjunctive therapy in adolescents and children aged six years and above, with partial (focal) epilepsy have been presented at the European Paediatric Neurology Society meeting, held this week in Brussels.
Three abstracts were presented. Two from study 313, an open-label extension of the paediatric CATZ Phase 3 trial, plus a pooled safety analysis reviewing data from 17 studies. Collectively, the data show an acceptable long-term safety profile with no consistent detrimental effects on growth and development skills, efficacy maintained for more than one year and an acceptable safety profile when used as an adjunctive treatment in paediatric patients, says Eisai.
Elena Belousova, director of psychoneurology and epileptology at the Moscow Research Institute of Paediatrics said that nearly one million children in Europe are affected by epilepsy, with an estimated 130,000 new cases diagnosed each year. New anti-epileptic drugs are needed for children and adolescents with epilepsy, she added.
Helen Cross at Great Ormond Street Hospital in London, commented: “There is no doubt that Zonegran (zonisamide) does appear to be having an impact on individuals where previous drugs have not worked and that is always exciting for us – a seizure freedom rate of 11% in a drug resistant population is very good. In clinical use, we have also noticed that children are not getting some of the side effects, such as drowsiness, that you get with some of the other drugs, which makes this something new for us to use.”
Eisai is currently awaiting final European Commission approval to extend the current indication for zonisamide in the EU to include adjunctive treatment of partial seizures with or without secondary generalisation for adolescents and children aged six years and above. A positive opinion from the Committee for Medicinal Products for Human Use at the European Medicines Agency was received in July 2013.
In general, Prof Cross was upbeat about the potential for new developments in epilepsy therapy. She said that exciting data presented at EPNS included a raft of presentations on the genetics of epilepsy: “Genetics is moving forward in a huge way, especially in respect of the early onset complex epilepsies.
“This is very exciting because we are finding the cause of the epilepsy and that will lead to new treatments. Most current drugs have been found by accident, tried in animal models and then developed as anti-epileptic drugs. With information about the cause, we can target our treatments.”
