Fycompatm (perampanel) is now available as an adjunctive treatment for adult patients
Eisai Limited has announced the Health Canada authorization and availability of FYCOMPA (perampanel) indicated as an adjunctive therapy in the management of partial-onset seizures, in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy. FYCOMPA is a first-in-class treatment authorized by Health Canada that selectively and non-competitively targets post-synaptic AMPA glutamate receptors, representing a new approach to seizure control.
Health Canada’s authorization of FYCOMPA was primarily based on three Phase III studies (304, 305 and 306). These multi-centre, randomized, double-blind, placebo-controlled, parallel group studies evaluated the efficacy and safety of FYCOMPA compared to placebo given as an adjunctive therapy in patients with partial-onset seizures.The studies demonstrated that FYCOMPA significantly reduced seizure frequency in patients with partial-onset seizures with or without secondarily generalized seizures.
"FYCOMPA represents an innovative approach in the treatment of epilepsy and a much needed option for Canadian patients and physicians," says Dr. Neelan Pillay, Clinical Professor, Director Adult Epilepsy Program, EEG and Evoked Potentials at the Department of Clinical Neurosciences, Foothills Medical Centre."When added to their current treatment regimen, FYCOMPA is shown to significantly reduce patients."
Epilepsy Canada President Dr. “Mac” Burnham said, "We have followed FYCOMPA's success in clinical trials and we welcome its release in Canada. It is always good to have a drug which works by a new mechanism. It gives us hope that the drug will be effective against seizures that have resisted the medicines currently available."
About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. About 70 per cent of people with epilepsy have partial-onset seizures. In about 30 per cent of patients with epilepsy, seizures cannot be controlled with treatment. In Canada, 300,000 Canadians currently live with epilepsy, and an estimated 15,500 are diagnosed each year. Despite the high epilepsy incidence, there still remains a relatively low understanding and awareness of this neurological disorder.
About FYCOMPA (perampanel)
FYCOMPA is an oral medication taken once-daily and is the first Health Canada-authorized selective and non-competitive post-synaptic AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain. Glutamate is the primaryexcitatory neurotransmitter in the central nervous system. FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets.
Discovered and developed by Eisai, FYCOMPA has been licensed in more than 30 countries including, the U.S., U.K., Germany, Sweden, Norway, Denmark, Austria and Switzerland. For more information on FYCOMPA, please refer to the product monograph for complete prescribing instructions. For more information about Eisai Limited, visit the company’s website www.eisai.ca
Discovered and developed by Eisai, FYCOMPA has been licensed in more than 30 countries including, the U.S., U.K., Germany, Sweden, Norway, Denmark, Austria and Switzerland. For more information on FYCOMPA, please refer to the product monograph for complete prescribing instructions. For more information about Eisai Limited, visit the company’s website www.eisai.ca
No comments:
Post a Comment