...Acorda Therapeutics, Inc. would like you to know that on January 30, 2009, they submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Fampridine-SR, a novel therapy developed to “improve walking ability” in people with multiple sclerosis.
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Currently, 4-aminopyridine (4-AP) is only available through compounding pharmacies, while Fampridine’s patented release formulation has been developed to provide a more consistent level of medication.
For lists of published studies regarding 4-AP and Fampridine-SR, see What is 4-aminopyridine? and 4-AP, Fampridine-SR, and Multiple Sclerosis. I had taken an interest in Acorda and Fampridine last summer, the result being a series of posts outlining the research involved in bringing this product to market.
The first clinical study of 4-aminopyridine in MS patients was published in 1983 and focused primarily on visual symptoms. The Phase 2 and two Phase 3 studies conducted by Acorda, total enrollment 660, focused on walking speed and lower leg strength. Through extension trials, 463 patients (approx 70%) continue to take Fampridine-SR with treatment duration ranging from seven months to almost five years.
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