April 14, 2004
The National Multiple Sclerosis Society
In a press release, Acorda Therapeutics announced today preliminary results of a phase 2 clinical trial of Fampridine-SR, an oral, sustained-release formula of 4-aminopyridine, to treat symptoms of multiple sclerosis.
Reporting on a dose-finding study involving individuals with several different forms of MS treated for 12 weeks, Acorda indicated that individuals on certain doses of the drug showed a trend (an effect which does not quite reach statistical significance) toward improved walking speed. The drug also showed a statistically significant ability to improve leg muscle strength. These data have not yet been published, and further analyses of the placebo-controlled trial results are under way. The press release states that the company plans to meet with the U.S. FDA to discuss additional clinical research that would be required before the drug could be submitted for marketing approval for the symptomatic treatment of MS.
Fampridine-SR blocks tiny pores, or potassium channels, on the surface of nerve fibers, and thus can improve the conduction of nerve signals in nerve fibers whose myelin coating has been damaged by MS.
The most common adverse events reported from this study were insomnia, paresthesias (pins and needles), dizziness and nausea. This drug has been tested in smaller studies previously, with mixed results. The company has also been conducting trials for its use in spinal cord injury.
Further research is needed to determine whether the drug can provide
meaningful improvements in everyday activities.
Copyright © 2004, The National Multiple Sclerosis Society