The European Commission (EC) has approved the paediatric licence variation of Zonegran (zonisamide), a novel anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AED.[1] Zonisamide is now indicated as an adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescents and children aged six years and above in addition to its existing license in adult patients.[1]
Epilepsy is a common condition in children and adolescents, affecting around 10.5 million worldwide, with nearly one million living in Europe.[2] However, only two thirds of these youngsters will achieve seizure control and many will require additional AEDs to improve seizure control.[3] Epilepsy in children often presents major challenges such as developmental and behavioural problems resulting in educational underachievement and a lack of self-esteem. These issues, which are frequently manifested in an attention deficit disorder, withdrawal, anxiety or depression, have a negative impact on both the child and their family.[4]
"It is pleasingthat Zonegran has now been licensed to be prescribed for children, as new options for young people with epilepsy are needed desperately," said Professor Helen Cross, Great Ormond Street Hospital and Young Epilepsy. "Epilepsyaffects all aspects of children and their family's lives. New, effective and well tolerated treatments that can be used in children to achieve a balance between stopping seizures and keeping side effects to a minimum are welcomed by doctors, patients and parents."
The zonisamide paediatric licence variation was based on Study 312 (CATZ) published in Epilepsia in July 2013.[5] These data from a double-blind, randomised, multicentre, placebo-controlled Phase III study, showed that significantly more patients responded positively to treatment with zonisamide (50%) versus treatment with placebo (31%), p=0.0044.[5] The overall incidence of treatment-emergent adverse events (TEAEs) was similar for zonisamide versus placebo.[5]
"We're delighted to announce Zonegran's EC paediatric license variation as the drug has the potential to improve the lives of many young people living with epilepsy," commented Gary Hendler, President and CEO, Eisai EMEA. "This licence variation strengthens our epilepsy portfolio, enabling us to help more people with epilepsy across a wide age range and achieve our vision of becoming the number one epilepsy company by 2015."
The continued development of zonisamide underscores Eisai's human health care mission, the company's commitment to innovative solutions in prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families. Eisai is proud to currently market more epilepsy products in EMEA than any other company.
Notes to Editors
About Zonegran (zonisamide)
Zonisamide is licensed in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Zonisamide is also indicated as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.[1] It has a broad spectrum of anti-epileptic modes of action and has no appreciable effects on steady-state plasma concentrations of other AEDs, such as phenytoin, carbamazepine and valproate.[1] Zonegran is one of only four AEDs with level A efficacy/effectiveness evidence as initial monotherapy for adults with partial onset seizures.[6]
Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended daily dose for monotherapy use is 100mg once daily. In the third and fourth weeks the dose may be increased to 200mg daily and then increased to 300mg daily after the next two weeks. The recommended initial daily dose for adjunctive use is 50mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg.[1]
See the article here:
European Commission Approves Licence Variation for Use of Zonegran® (zonisamide) in Children With Partial Epilepsy