New first-in-class epilepsy treatment Fycompa® (perampanel) launches in Russia
Fycompa(R) (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.
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. 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 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. Around 3 out of every 1,000 people in Russia live with the condition, 82% of which have partial (focal) epilepsy.
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). 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.,, The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.,, Results from the open-label extension study also demonstrate perampanel's efficacy and favorable tolerability profile over the longer term.
"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.
About Fycompa(R) (perampanel)
Perampanel 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.
Perampanel is a highly selective, non-competitive AMPA ( alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy.
Further information for healthcare professionals can be found at http://www.fycompa.eu.
Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide., Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.