Hatfield, England (ots/PRNewswire) Zonegran(R) (zonisamide) receives approval in Russia for the treatment of partial epilepsy in children and adolescents. Zonisamide, a novel anti-epileptic drug (AED) with multiple mechanisms of action and a chemical structure unrelated to any other AED, is indicated in Russia and 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, adolescents and children aged six years and above.[1]
Epilepsy is one of the most common neurological diseases in the world.[2] Around three out of every 1,000 people in Russia live with epilepsy, 82% of whom have partial (focal) epilepsy.[3] Epilepsy diagnosed in childhood has long-term implications for health and well-being and timely diagnosis and appropriate treatment are essential.[4] Although epilepsy is common among children, only two thirds of those with the condition will achieve seizure control and many will require additional AEDs to improve seizure control.[5]
It is good news that we have a new treatment option available for children and adolescents with partial epilepsy in Russia. Epilepsy can affect every aspect of a childs and their familys life; well-tolerated and effective treatments are therefore very welcome, commented Andrey Petrukhin, Professor of the Child Neurology Department at the Russian State Medical University, Russia.
This paediatric approval in Russia is based on Study 312 (CATZ) published in Epilepsia in July 2013.[6] The double-blind, randomised, multicentre, placebo-controlled Phase III study showed that significantly more patients responded positively to treatment with zonisamide (50%) compared to treatment with placebo (31%), p=0.0044.[6] The overall incidence of treatment-emergent adverse events (TEAEs) was similar in patients receiving zonisamide compared to placebo.[6] These data are supported by results from the long-term Phase III study (Study 313), which demonstrate that zonisamise is well tolerated and efficacious when used as an adjunctive treatment in children aged between 6-17 years for at least one year.[7]
The availability of Zonegran in Russia for use in children and adolescents is in line with our on-going commitment to the therapeutic area of epilepsy and our drive to increase the benefits provided through our medicines, commented Olga Konopleva, Managing Director, Eisai Russia.
The continued development of zonisamide underscores Eisais human health care (hhc) mission, the companys commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of epilepsy and to address the unmet medical needs of people with epilepsy and their families. Eisai is proud to market currently 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 in Europe as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged six years and above.[8] 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] Worldwide there has been an estimated 1,274,963 patient-years of exposure to zonisamide (from 31.03.1989 to 31.03.2013).[9]
Zonisamide is available in 25mg, 50mg, and 100mg capsule strengths. The recommended initial daily dose for adjunctive use in children aged 6 and above is 1mg/kg. The recommended daily dose is 6-8mg/kg/day for patients weighing 22-55kg and 300-500mg/day for patients over 55kg.[8]
Follow this link:
Eisai Receives Approval in Russia for its Antiepileptic Treatment Zonegran (Zonisamide) for Use in Children and ...