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
Tuesday 23 July 2013
Friday 5 July 2013
Innovative EpLink Research Funded through 2018
A recent funding announcement from the Ontario Government has assured that EpLink - the Epilepsy Research Program co-directed by Epilepsy Canada President Dr. Mac Burnham - will maintain its funding through 2018. EpLink is a major initiative of the Ontario Brain Institute, which received the news of its extended funding in March of this year.
The EpLink Epilepsy Program is unique in Canada, linking more than twenty-five researchers (working at nine different university and hospital sites across Ontario), five industry partners, five non-profit advocacy groups and a national NFP organization dedicated to epilepsy research.The EpLink Program will bring these workers more the $2 million per year in research support. Dr. Burnham shares responsibility for direction of the program with Dr. Jorge Burneo of London, Ontario. It’s his hope that EpLink’s influence will spread far beyond the province’s borders and will form a template that can be adopted by provincial governments all across Canada.
Dr. Burnham notes that the goals of the EpLink Program are translational in nature. Though its studies involve cutting edge science, its major focus is to improve clinical care for epilepsy in the very near future. To accomplish this goal, EpLink is partnering with industry, since its support is necessary to bring new discoveries from bench to bedside. EpLink is also partnering with non-profit regional and provincial epilepsy associations in Ontario.
The research projects supported by the EpLink Program involve almost every area of epilepsy care. They are divided into six different themes: 1) Epidemiology and Diagnosis, 2) Medical Control of Seizures – Pharmacological, 3) Medical Control of Seizures – Non-Pharmacological, 4) Imaging for Surgery, 5) Surgery and Stimulation and 6) Genetics and Epigenetics. While there is not space to describe all of the projects, reviewing a few of them may give some sense of the depth and breadth of the EpLink Program.
In Epidemiology and Diagnosis, for instance, Dr. Michele Shapiro in Hamilton is testing whether longer initial EEGs will more accurately diagnose epilepsy after the first seizure, whereas Dr. Jorge Burneo in London is trying to assess the number of patients who develop epilepsy after traumatic brain injury and Dr. Elizabeth Donner in Toronto is studying the occurrence of SUDEP and the risk factors associated with it.
The Medical Control of Seizures – Pharmacological relates to drug development and delivery. Dr. McIntyre Burnham in Toronto, for instance, is involved in the pre-clinical testing drugs related to the ketogenic diet, while Dr. Peter Carlen is working on the transmucosal delivery of benzodiazepines to treat cluster seizures.
The theme of Medical Control of Seizures – Non-Pharmacological involves quite a variety of interesting projects. In Hamilton, Dr. Gabriel Ronen is testing whether physical exercise can improve seizure control, while in Ottawa; Dr. Sharon Whiting is investigating the cost-effectiveness of diet therapy – a treatment that should be more widely used. Dr. Elizabeth Kerr in Toronto is testing whether a computer-based training program can improve working memory in children with epilepsy – a study which maybe the first of a number of projects targeting the co-morbidities of epilepsy.
Surgery is the only real cure for epilepsy, and the increasing success of surgery has been largely based on improvements in non-invasive imaging. Imaging for Surgery is one of our most technically advanced themes, with a number of studies focused on MRI and MEG. Dr. Rob Bartha in London, for instance is using 7T MRI to re-screen patients previously screened with 3T MRI. The hope is that the more powerful technique will identify structural abnormalities missed in the earlier screening. Drs. Peters and Khan, also in London, are trying to fuse multi-spectral imaging techniques to create an atlas of epileptogenic brain tissue to assist surgery. Drs. Cheyne and Otsubo in Toronto are working to combine MEG and MRI for more accurate localization of interictal spikes, while Drs. Doesburg and Snead, also at the Hospital for Sick Children, are mapping network connectivity to improve the localization of epileptogenic foci.
The largest project in our Surgery and Stimulation theme relates to the development of computerized systems to detect seizure onset and to suppress seizures with brain stimulation. This effort is being led by Drs. Carlen, Bardakjian and Valiante at the Toronto Western Hospital, with related studies at the Hospital for Sick Children being conducted by Drs. Perez-Velazquez and Otsubo. Additional projects relate to monitoring the effects of surgery on quality of life (Dr. Mary Lou Smith) and predicting the memory deficits that may be caused by seizure surgery (Dr. Mary Pat McAndrews).
Our most "basic science" theme is Genetics and Epigenetics. The payoff from these studies may be some years away, but the impact will be very great. Dr. Danielle Andrade in Toronto, for instance, is studying the genetics of inherited temporal lobe, whereas Dr. Michael Poulter in London is studying methylation patterns in excised epileptic foci. Drs. Cortez and Snead are investigating the exciting possibility that early environment may prevent development of the phenotype in an animal model of West's syndrome.
Readers interested in more information can email Dr. Kathryn Hum, the EpLink Project Manager at eplink.obi@gmail.com or access the EpLink website at www.eplink.ca.
The EpLink Epilepsy Program is unique in Canada, linking more than twenty-five researchers (working at nine different university and hospital sites across Ontario), five industry partners, five non-profit advocacy groups and a national NFP organization dedicated to epilepsy research.The EpLink Program will bring these workers more the $2 million per year in research support. Dr. Burnham shares responsibility for direction of the program with Dr. Jorge Burneo of London, Ontario. It’s his hope that EpLink’s influence will spread far beyond the province’s borders and will form a template that can be adopted by provincial governments all across Canada.
Dr. Burnham notes that the goals of the EpLink Program are translational in nature. Though its studies involve cutting edge science, its major focus is to improve clinical care for epilepsy in the very near future. To accomplish this goal, EpLink is partnering with industry, since its support is necessary to bring new discoveries from bench to bedside. EpLink is also partnering with non-profit regional and provincial epilepsy associations in Ontario.
The research projects supported by the EpLink Program involve almost every area of epilepsy care. They are divided into six different themes: 1) Epidemiology and Diagnosis, 2) Medical Control of Seizures – Pharmacological, 3) Medical Control of Seizures – Non-Pharmacological, 4) Imaging for Surgery, 5) Surgery and Stimulation and 6) Genetics and Epigenetics. While there is not space to describe all of the projects, reviewing a few of them may give some sense of the depth and breadth of the EpLink Program.
In Epidemiology and Diagnosis, for instance, Dr. Michele Shapiro in Hamilton is testing whether longer initial EEGs will more accurately diagnose epilepsy after the first seizure, whereas Dr. Jorge Burneo in London is trying to assess the number of patients who develop epilepsy after traumatic brain injury and Dr. Elizabeth Donner in Toronto is studying the occurrence of SUDEP and the risk factors associated with it.
The Medical Control of Seizures – Pharmacological relates to drug development and delivery. Dr. McIntyre Burnham in Toronto, for instance, is involved in the pre-clinical testing drugs related to the ketogenic diet, while Dr. Peter Carlen is working on the transmucosal delivery of benzodiazepines to treat cluster seizures.
The theme of Medical Control of Seizures – Non-Pharmacological involves quite a variety of interesting projects. In Hamilton, Dr. Gabriel Ronen is testing whether physical exercise can improve seizure control, while in Ottawa; Dr. Sharon Whiting is investigating the cost-effectiveness of diet therapy – a treatment that should be more widely used. Dr. Elizabeth Kerr in Toronto is testing whether a computer-based training program can improve working memory in children with epilepsy – a study which maybe the first of a number of projects targeting the co-morbidities of epilepsy.
Surgery is the only real cure for epilepsy, and the increasing success of surgery has been largely based on improvements in non-invasive imaging. Imaging for Surgery is one of our most technically advanced themes, with a number of studies focused on MRI and MEG. Dr. Rob Bartha in London, for instance is using 7T MRI to re-screen patients previously screened with 3T MRI. The hope is that the more powerful technique will identify structural abnormalities missed in the earlier screening. Drs. Peters and Khan, also in London, are trying to fuse multi-spectral imaging techniques to create an atlas of epileptogenic brain tissue to assist surgery. Drs. Cheyne and Otsubo in Toronto are working to combine MEG and MRI for more accurate localization of interictal spikes, while Drs. Doesburg and Snead, also at the Hospital for Sick Children, are mapping network connectivity to improve the localization of epileptogenic foci.
The largest project in our Surgery and Stimulation theme relates to the development of computerized systems to detect seizure onset and to suppress seizures with brain stimulation. This effort is being led by Drs. Carlen, Bardakjian and Valiante at the Toronto Western Hospital, with related studies at the Hospital for Sick Children being conducted by Drs. Perez-Velazquez and Otsubo. Additional projects relate to monitoring the effects of surgery on quality of life (Dr. Mary Lou Smith) and predicting the memory deficits that may be caused by seizure surgery (Dr. Mary Pat McAndrews).
Our most "basic science" theme is Genetics and Epigenetics. The payoff from these studies may be some years away, but the impact will be very great. Dr. Danielle Andrade in Toronto, for instance, is studying the genetics of inherited temporal lobe, whereas Dr. Michael Poulter in London is studying methylation patterns in excised epileptic foci. Drs. Cortez and Snead are investigating the exciting possibility that early environment may prevent development of the phenotype in an animal model of West's syndrome.
Readers interested in more information can email Dr. Kathryn Hum, the EpLink Project Manager at eplink.obi@gmail.com or access the EpLink website at www.eplink.ca.
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