Epilepsy is a common condition in children and adolescents, affecting around 10.5 million worldwide, with nearly one million living in Europe.[4],[5]Although epilepsy is common among children and adolescents, only two thirds will achieve seizure control and many will require additional AEDs to improve seizure control.[6]
Two of the abstracts focus on long-term safety and efficacy data for zonisamide as an adjunctive therapy in paediatric patients (6 - 18 years old) with partial epilepsy.[7] The first study demonstrated an acceptable long-term (>1 year) safety profile versus placebo with no consistent detrimental effects on growth and development skills.[4] The second demonstrated that efficacy versus placebo in this patient group was maintained over a treatment period of >1 year.[5] A third study presented is a pooled safety analysis of 17 studies and demonstrated that zonisamide has an acceptable safety profile when used as an adjunctive treatment in paediatric patients.[6]
Zonisamide is an anti-epileptic drug (AED) with multiple mechanisms of action and a structure which is chemically unrelated to any other AED.[8] Zonisamide is indicated in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults.[4]
The zonisamide CHMP positive opinion and EMA application file are based on Study 312 (CATZ) published in Epilepsia in July 2013.[7] 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.[7] The overall incidence of treatment-emergent adverse events (TEAEs) was similar for zonisamide versus placebo.[7]
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.[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.[9]
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]
For more information please visit: http://www.zonegran.eu
Excerpt from:
New Data For Zonegran® (Zonisamide) to be Presented at The European Paediatric Neurology Society Congress