February 2, 2009
The maker of a therapy targeted at improving walking ability in people with MS has applied for FDA approval of the drug, Fampridine-SR.
Fampridine does not slow the progression of MS but in recent phase III clinical trials, nearly 43 percent of those who took fampridine – also sometimes called 4-aminopyridine or 4-AP – showed consistent improvement in their walking speed, compared to 9.3 percent of people who took placebo. Those people who showed improvement walking while taking the drug took, on average, about 25 percent less time to walk 25 feet.
Reported side effects included urinary tract infection, insomnia and headache, among others. 4-AP already is available through compounding pharmacists, but is generally not covered by insurance plans.
In addition to submitting a New Drug Application to the FDA, Acordia Therapeutics has plans to file for approval with European regulatory authorities at a future date.
source: MS Foundation.
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3 comments:
how do the american public with m.s. get ahold of this drug/
Ampyra is Approved for sale in the USA for MS patients, to help them walk better. A prescription from the MS Patient's doctor is needed
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