First and Only Selective, Non-Competitive AMPA Glutamate Receptor Antagonist
MISSISSAUGA, ON, July 10, 2013 /CNW/ - Eisai Limited is pleased to announce 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.1
"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, Department of Clinical Neurosciences, Foothills Medical Centre. "When added to their current treatment regimen, FYCOMPA is shown to significantly reduce seizures in patients."
In Canada, 300,000 Canadians currently live with epilepsy2, and an estimated 15,500 are diagnosed each year3. Despite the high epilepsy incidence, there still remains a relatively low understanding and awareness of this neurological disorder.4
"Health Canada's authorization of FYCOMPA marks another important milestone for Canadian epilepsy patients with partial-onset seizures who now have a new option that is proven to control their seizures," says Oliver Technow, President and General Manager, Eisai Limited. "Eisai's human healthcare (hhc) philosophy centres around improving the health and quality of life for patients and their families and we are committed to improving these lives by providing innovative therapies that can have a positive impact."
"The epilepsy community celebrates the authorization of FYCOMPA as an additional tool to manage the disorder," says Gail Dempsey, President, Canadian Epilepsy Alliance. "Access to new options is key - every patient responds differently to a treatment and it is our goal as a community to ensure the tools are available, so that patients can live a fulfilling and rewarding life."
In the three clinical studies, most adverse events in all treatment groups were considered mild or moderate in severity. The most common adverse events (greater than or equal to 5 per cent) in patients treated with FYCOMPA were dizziness, somnolence, fatigue, irritability, nausea, ataxia and falls.
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.5 In about 30 per cent of patients with epilepsy, seizures cannot be controlled with treatment.6
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New Approach for the Treatment of Epilepsy Authorized by Health Canada - FYCOMPA(TM) (perampanel) is Now Available as ...