Sunday, February 8, 2009

Acorda Therapeutics seeking FDA-approval for Fampridine-SR

...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.

Read this post in its entirety:

Does the demyelination from multiple sclerosis affect your ability to walk?


  1. I have been taking 4-AP for a few months now. I'm getting it from a compounding pharmacy with a script. I did notice a marked improvement in my gait almost immediately. I still flare and have my rougher days, but I'm convinced it has helped a great deal.

  2. I'm only familiar with this from Bubbie's stories and this blog but it seems to be helping Bubbie so it sounds like a good thing.

  3. Ditto on what DR says up there (cuz I'm too lazy to think of anything creative to say myself)

  4. I wonder if this is what my neurologist said he may have me try? He said it was a clinical trial and taken orally. Interesting.... Thanks for the great info!

  5. Hi!

    Lisa from what I'm reading here this seems like a drug I would try because it helps improve quality of life and has moderate side effects.