Tuesday, December 01, 2009

MS Walking Improvement Drug Gets FDA Help


Fampridine-SRMost of the MS therapies in the drug development pipeline, or even available today, are targeted at reducing relapses and decreasing disability progression.

It makes Acorda Therapeutics Fampridine-SR quite interesting. In Phase III trials, it is targeted specifically at one particularly onerous aspect of the MS burden impact on walking ability.

Acorda and the United States Food and Drug Administration recently reached an agreement on a pathway to getting Fampridine approved for this indication. In addition to a Phase III trial currently underway, Acorda will work with the FDA''s Special Protocol Assessment to ensure their trial design proves that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo...

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