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New MS drug “is safe and effective”


Acorda Therapeutics’s experimental multiple-sclerosis drug Fampridine-SR appears safe and effective, according to a panel of the US Food and Drug Administration (FDA).

The disease affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems.

Fampridine is intended to improve patients’ ability to walk.
The FDA panel heard that, in trials, the drug caused significant improvement in walking ability, although the actual time to complete test exercises did not improve.

An increased risk of seizures with the drug at 20 milligrams – twice the recommended dose – can be addressed after it is approved, the panel said.

FDA is scheduled to make a decision on the drug by 22 October. It is not required to follow the panel’s advice, though it usually does.

Copyright © Press Association 2009


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