| FDA has approved the marketing of Ampyra™ |
| Written by Gus, MT | |||||||
| Friday, 22 January 2010 | |||||||
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The U.S. Food and Drug Administration has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR, from Acorda Therapeutics) for its ability to improve walking speed in people with any type of multiple sclerosis.
Ampyra is the first therapy specifically approved to treat a symptom of MS, and as an oral drug it represents a big step forward for many people who may benefit from its use. Ampyra is also the first new FDA approved therapy for MS since 2004. "The FDA's approval of Ampyra is wonderful news for many people with MS who experience problems with walking," said John R. Richert, MD, Executive Vice President for Research & Clinical Programs at the National MS Society. "This brings a welcome symptomatic therapy that may restore some function and make a real difference in quality of life for a large number of people with different types of MS." Further study and clinical practice may help determine the extent to which the drug may impact other functions not measured in the clinical trials, and provide hints as to which individuals are most likely to respond. Ampyra, formerly known as fampridine SR, is a tablet containing a sustained-release formula of 4-aminopyridine, which blocks tiny pores, or potassium channels, on the surface of nerve fibers. This blocking ability may improve the conduction of nerve signals in nerve fibers whose insulating myelin coating has been damaged by MS. The first studies of this potassium-blocking approach in people with MS were supported by the National MS Society. A recent survey among more than 1,000 individuals with MS and many of their family members examined the impact of difficulty walking on quality of life among patients with MS and their families. Some two-thirds of patients reported difficulty walking and of these, 70% reported that such difficulty was the most challenging part of their MS, and most reported that difficulty walking restricts their daily activities significantly, including their ability to travel. (Read more about survey results)
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