Seeing
the drug referred with two names confused me because separate press
releases never mentioned the drug is called by either name... but the
M.S. Resource Center of the U.K. makes it clear.
http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1310/text/3
Ampyra (Fampyra)
Ampyra (Fampridine-SR) is a sustained-release tablet formulation of the drug fampridine (4-aminopyridine, or 4-AP).
Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.
Biogen Idec Canada announces that Fampyra (fampridine sustained release tablets or fampridine SR) is now available for prescription for patients living with multiple sclerosis (MS) in Canada.
Health Canada approved Fampyra on February 10, 2012 for the symptomatic improvement of walking in adult MS patients with walking disability (EDSS 3.5-7).
Walking impairment is one of the most common and disruptive consequences of MS and Fampyra is the first approved treatment that addresses this unmet medical need. In clinical trials, it demonstrated efficacy in people with all types of MS.
Patients with MS consistently rate walking as the most important function they want to maintain, regardless of what stage they are in their disease. Walking impairment is directly associated with loss of independence, restrictions on a patient's ability to work and a reduction in overall levels of household income. In fact, a research survey shows that 88 per cent of sampled Canadians living with MS report that difficulty walking affects their overall mobility.
"For patients with MS, one of the greatest areas affected in their lives is walking. Until fampridine SR (Fampyra), there have been no pharmacologic agents shown to directly improve walking function in persons with multiple sclerosis," said Dr. Christine Short, Associate Professor, Department of Medicine, Division of Physical Medicine and Rehabilitation, Dalhousie University, Halifax, NS. "As a clinician who manages persons with multiple sclerosis, the approval of this treatment in Canada represents a real breakthrough in our battle to help individuals maintain independence and quality of life in the face of a progressive neurologic disease."
MS is an unpredictable, often debilitating disease of the central nervous system that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage. When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted. Studies show that Fampyra can increase conduction along damaged nerves and enable signals to pass down the nerve more normally, which may result in improved walking for adult MS patients.
Clinical Data Demonstrates Efficacy The approval of Fampyra for the improvement of walking in adult patients with MS was based on the results of two Phase III clinical trials: MS-F203 and MS-F204.
The primary endpoint was the responder rate based on walking speed as measured by the Timed 25-Foot Walk (T25FW). A significantly greater proportion of patients taking Fampyra had consistent improvement in walking speed when compared to placebo (ms-f203:34.8 per cent to 8.3 per cent)(and ms-f204:42.9 per cent to 9.3 per cent). In patients who responded to therapy in the two studies, MS-F203 and MS-F204, Fampyra increased their walking speed on average by 26.3 per cent to 5.3 per cent on placebo, and 25.3 per cent to 7.8 per cent, respectively.
"Seeing the effects of these results will have an important impact on patients," said Dr. Brad Stewart, Neurologist and Assistant Clinical Professor, University of Alberta, Edmonton, Alberta. "As mobility impairment in MS is progressive, Fampyra is a welcomed, new treatment to address this unmet need in the management of walking difficulties."
Important Safety Information The use of Fampyra is contraindicated in patients with a known hypersensitivity to fampridine or any ingredient in the formulation; currently on treatment with other forms of 4-aminopyridine, dalfampridine or fampridine; with a history of mild, moderate or severe renal impairment; or with a history of seizure or medically assessed as at high risk of seizure.
Fampyra should only be used under the supervision of a clinician experienced in the treatment of MS and familiar with the safety and efficacy of Fampyra. The recommended dose of one sustained release 10 mg tablet twice daily, taken 12 hours apart, should not be exceeded.
The most common adverse events with incidence greater than or equal to two per cent and at a rate greater than the placebo rate for Fampyra were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, paraesthesia, nasopharyngitis and constipation.
Source: Market Watch Copyright © 2012 MarketWatch, Inc (11/04/12)
Interactive website for Ampyra® (Dalfampridine) MS users launched
Acorda Therapeutics, Inc. has announced the launch of a new interactive patient website called Ampyra Journeys. The site is the first-ever stand-alone patient site to focus on walking problems associated with multiple sclerosis (MS). Ampyra (dalfampridine) is an oral medication approved by the FDA as a treatment to improve walking in patients with multiple sclerosis. This was demonstrated by an increase in walking speed.
The Ampyra Journeys website features true stories of people living with MS who have experienced walking problems and who took action to get treatment. Their stories explore the impact that walking problems can have for people living with MS, and how treatment that leads to improvements in walking can help people to regain the ability to perform many daily tasks. Prominent MS patient advocate, motivational speaker and entertainer Kristie Salerno Kent is among the patients who share their personal stories on www.AmpyraJourneys.com.
“I have met so many people living with MS who did not seek help when they started to experience walking problems. The important news is that treatment is available, and so I am very excited to be involved with Ampyra Journeys. This new website is a vital resource that can help anyone living with MS to learn about, and to do something about, MS-related walking problems,” said Ms. Salerno Kent.
Walking problems are a significant concern for people living with MS. According to a 2011 Harris Interactive Survey, approximately 70% of people with MS who experience difficulty walking identify this issue as the biggest challenge associated with MS.
Visitors to the website can also download “Let’s Talk About Walking and MS,” a guide with tips on how to talk about walking problems with a healthcare provider.
“Acorda Therapeutics developed Ampyra to help patients with walking problems, one of the most challenging and common symptoms of MS. Now we are very pleased to present Ampyra Journeys, to help more people get the support they need to get treatment. It's our hope that this site will educate and inspire people to seek help for their MS-related walking problems,” said Ron Cohen, MD, president and CEO of Acorda Therapeutics.
Source: EON ©2012 Business Wire (03/04/12)
http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1310/text/3
Ampyra (Fampyra)
Ampyra (Fampridine-SR) is a sustained-release tablet formulation of the drug fampridine (4-aminopyridine, or 4-AP).
Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.
Biogen Idec Canada announces that Fampyra (fampridine sustained release tablets or fampridine SR) is now available for prescription for patients living with multiple sclerosis (MS) in Canada.
Health Canada approved Fampyra on February 10, 2012 for the symptomatic improvement of walking in adult MS patients with walking disability (EDSS 3.5-7).
Walking impairment is one of the most common and disruptive consequences of MS and Fampyra is the first approved treatment that addresses this unmet medical need. In clinical trials, it demonstrated efficacy in people with all types of MS.
Patients with MS consistently rate walking as the most important function they want to maintain, regardless of what stage they are in their disease. Walking impairment is directly associated with loss of independence, restrictions on a patient's ability to work and a reduction in overall levels of household income. In fact, a research survey shows that 88 per cent of sampled Canadians living with MS report that difficulty walking affects their overall mobility.
"For patients with MS, one of the greatest areas affected in their lives is walking. Until fampridine SR (Fampyra), there have been no pharmacologic agents shown to directly improve walking function in persons with multiple sclerosis," said Dr. Christine Short, Associate Professor, Department of Medicine, Division of Physical Medicine and Rehabilitation, Dalhousie University, Halifax, NS. "As a clinician who manages persons with multiple sclerosis, the approval of this treatment in Canada represents a real breakthrough in our battle to help individuals maintain independence and quality of life in the face of a progressive neurologic disease."
MS is an unpredictable, often debilitating disease of the central nervous system that attacks the protective covering, or myelin, of the brain and spinal cord, causing inflammation and damage. When this occurs, the normal flow of nerve impulses along nerve fibres, or axons, becomes disrupted. Studies show that Fampyra can increase conduction along damaged nerves and enable signals to pass down the nerve more normally, which may result in improved walking for adult MS patients.
Clinical Data Demonstrates Efficacy The approval of Fampyra for the improvement of walking in adult patients with MS was based on the results of two Phase III clinical trials: MS-F203 and MS-F204.
The primary endpoint was the responder rate based on walking speed as measured by the Timed 25-Foot Walk (T25FW). A significantly greater proportion of patients taking Fampyra had consistent improvement in walking speed when compared to placebo (ms-f203:34.8 per cent to 8.3 per cent)(and ms-f204:42.9 per cent to 9.3 per cent). In patients who responded to therapy in the two studies, MS-F203 and MS-F204, Fampyra increased their walking speed on average by 26.3 per cent to 5.3 per cent on placebo, and 25.3 per cent to 7.8 per cent, respectively.
"Seeing the effects of these results will have an important impact on patients," said Dr. Brad Stewart, Neurologist and Assistant Clinical Professor, University of Alberta, Edmonton, Alberta. "As mobility impairment in MS is progressive, Fampyra is a welcomed, new treatment to address this unmet need in the management of walking difficulties."
Important Safety Information The use of Fampyra is contraindicated in patients with a known hypersensitivity to fampridine or any ingredient in the formulation; currently on treatment with other forms of 4-aminopyridine, dalfampridine or fampridine; with a history of mild, moderate or severe renal impairment; or with a history of seizure or medically assessed as at high risk of seizure.
Fampyra should only be used under the supervision of a clinician experienced in the treatment of MS and familiar with the safety and efficacy of Fampyra. The recommended dose of one sustained release 10 mg tablet twice daily, taken 12 hours apart, should not be exceeded.
The most common adverse events with incidence greater than or equal to two per cent and at a rate greater than the placebo rate for Fampyra were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, paraesthesia, nasopharyngitis and constipation.
Source: Market Watch Copyright © 2012 MarketWatch, Inc (11/04/12)
Interactive website for Ampyra® (Dalfampridine) MS users launched
Acorda Therapeutics, Inc. has announced the launch of a new interactive patient website called Ampyra Journeys. The site is the first-ever stand-alone patient site to focus on walking problems associated with multiple sclerosis (MS). Ampyra (dalfampridine) is an oral medication approved by the FDA as a treatment to improve walking in patients with multiple sclerosis. This was demonstrated by an increase in walking speed.
The Ampyra Journeys website features true stories of people living with MS who have experienced walking problems and who took action to get treatment. Their stories explore the impact that walking problems can have for people living with MS, and how treatment that leads to improvements in walking can help people to regain the ability to perform many daily tasks. Prominent MS patient advocate, motivational speaker and entertainer Kristie Salerno Kent is among the patients who share their personal stories on www.AmpyraJourneys.com.
“I have met so many people living with MS who did not seek help when they started to experience walking problems. The important news is that treatment is available, and so I am very excited to be involved with Ampyra Journeys. This new website is a vital resource that can help anyone living with MS to learn about, and to do something about, MS-related walking problems,” said Ms. Salerno Kent.
Walking problems are a significant concern for people living with MS. According to a 2011 Harris Interactive Survey, approximately 70% of people with MS who experience difficulty walking identify this issue as the biggest challenge associated with MS.
Visitors to the website can also download “Let’s Talk About Walking and MS,” a guide with tips on how to talk about walking problems with a healthcare provider.
“Acorda Therapeutics developed Ampyra to help patients with walking problems, one of the most challenging and common symptoms of MS. Now we are very pleased to present Ampyra Journeys, to help more people get the support they need to get treatment. It's our hope that this site will educate and inspire people to seek help for their MS-related walking problems,” said Ron Cohen, MD, president and CEO of Acorda Therapeutics.
Source: EON ©2012 Business Wire (03/04/12)
No comments:
Post a Comment