Zonisamide approved for use on children with partial epilepsy
Zonisamide, a novel anti-epileptic drug (AED) sold under the trade name Zonegran, has been approved for paediatric use and can now be prescribed in the UK as a therapy for partial epilepsy in adolescents and children aged six years and above.
According to pharmaceutical company Eisai, zonisamide features “multiple mechanisms of action” and a chemical structure “unrelated to any other AED” – meaning it represents an exciting new avenue of treatment for clinicians.
“It is pleasing that Zonegran has now been licensed to be prescribed for children, as new options for young people with epilepsy are needed desperately,” commented Professor Helen Cross of Great Ormond Street Hospital.
“New, effective and well tolerated treatments that can be used in children that achieve a balance between stopping seizures and keeping side effects to a minimum are welcomed by doctors, patients and parents.”
Zonisamide is currently used to treat partial seizures in adults with newly diagnosed epilepsy, or as an adjunctive therapy.
The paediatric license extension means that almost one million further patients in Europe will be able to legally obtain the drug, including 63,000 children and adolescents living in the UK. The fact that zonisamide is a novel AED is particularly welcome, given that a large proportion of people with epilepsy do not respond to conventional therapies.
It was approved on the basis of a Phase III study, published in the journal Epilepsia in July, that used a placebo-controlled trial of 207 children with partial epilepsy. It found that 50 per cent of patients responded positively to zonisamide, compared with just 31 per cent whose seizures were halted by the dummy treatment.
Similarly, the children who took the drug were not found to be significantly more likely to exhibit negative side effects than their counterparts who were given the placebo instead. Just 3.7 per cent of those who used zonisamide experienced serious treatment-emergent adverse events, compared with two per cent of the control group.
Posted by Steve Long