HATFIELD, England, June 9, 2014 /PRNewswire/ --
Fycompa (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has today launched in Russia. The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[1]
Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a critical role in the spread of seizures.[2] This mechanism of action is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime[1] and, significantly, is the only new-generation partial epilepsy treatment approved to treat adolescents with epilepsy from launch.
"New treatment options like perampanel are vital for people with partial onset epilepsy in Russia, and particularly those who live with uncontrolled seizures," commented Professor Elena Belousova, Director of Psychoneurology and Epileptology, Moscow Research Institute of Pediatrics. "Epilepsy remains a challenging condition to treat and new options such as this are always welcomed by doctors."
Epilepsy is one of the most common neurological conditions in the world.[3] Around 3 out of every 1,000 people in Russia live with the condition, 82% of which have partial (focal) epilepsy.[4]
Perampanel's availability in Russia is based on three randomised, double-blind, placebo-controlled and dose-escalated global pivotal Phase III studies (304, 305, 306) and an open-label extension study (307).[5] The three global pivotal studies show consistent results in the efficacyand tolerability of perampanel as an adjunctive therapy in people with partial onset seizures, with or without secondary generalisation.[6],[7],[8] The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.[6],[7],[8] Results from the open-label extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.[5]
"We are pleased to announce the launch of Fycompa in Russia as Eisai is committed to the development of innovative epilepsy therapies such as this to help people improve their seizure control," commented Olga Konopleva, Managing Director, Eisai Russia.
Discovered and developed by Eisai in Europe and Japan, perampanel is manufactured in the UK and was approved by the European Commission on 23 July 2012. The launch of perampanel in Russia underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.
Notes to Editors
About Fycompa(perampanel)
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New First-in-class Epilepsy Treatment Fycompa (perampanel) Launches in Russia