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 | MS Walking Improvement Drug Gets FDA Help |
 Most of the MS therapies in the drug development pipeline, or even available today, are targeted at reducing relapses and decreasing disability progression.
Which 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 (SPA) 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...
Story continues, please click ''read more''
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Posted by Administrator on Wednesday, May 23 @ 19:09:16 CDT (11028 reads)
(Read More... | 1346 bytes more | Score: 5)
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| News: Acorda Gets FDA Assistance for Phase III Trial of Fampridine-SR |
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Acorda Therapeutics announced today that the United States Food and Drug Administration has agreed to a Special Protocol Assessment for Acorda''s Phase III trial of Fampridine-SR, a treatment aimed at improving walking in MS''ers. The Special Protocol Assessment means that the FDA will provide guidance to Acorda as they design their Phase III trial. The hope is that this extra step will help eliminate any mis-steps in protocol or structure. As implied by the agreement, the trial is still in the planning phase.
Primary outcome for the clinical trial will be improvement in walking, measured by various common scales. More generally the drug aims to decrease overall spasticity.
Please click "read more" for the full press release.
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Posted by Administrator on Wednesday, May 04 @ 13:04:15 CDT (3994 reads)
(Read More... | 4176 bytes more | News | Score: 4.5)
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| Story on Upcoming MS Therapy Fampridine |
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Just a bit piece on Fampridine, which is a new drug in the final stages of clinical trials that helps nerve transmission.
The full article can be read by clicking "Read More." Here''s an excerpt:
"Researchers around the country are looking at a medication that may help people with MS. They''re hoping the new drug will help improve walking and quality of life...
Dr. Bill Lindsey, a neurologist, says a pill, Fampridine, may make life a little easier for people with MS, "If it improves walking speed for people who are using canes or walkers, then they''ll be able to get around their house better and do more things in the day."
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Posted by Administrator on Sunday, December 28 @ 15:05:38 CST (2764 reads)
(Read More... | 2822 bytes more | Score: 3)
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| News: Pill May Help MS Patients Walk More Easily |
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A new pill, called Fampridine-SR, may improve mobility in people with MS.
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Posted by Administrator on Wednesday, November 12 @ 13:46:19 CST (6914 reads)
(Read More... | 2583 bytes more | News | Score: 4.18)
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