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Thread: Acorda Therapeutics scores on MS trials.

  1. #1
    Super Moderator Sue Pendleton's Avatar
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    Thumbs up Acorda Therapeutics scores on MS trials.

    http://phx.corporate-ir.net/phoenix....8496&highlight=

    Instead of using spasticity as an end point as they did during the SCI trials the MS trials used walking abilities and leg strength. Here's to great and fast results by the FDA new drug approval unit.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  2. #2
    Senior Member lynnifer's Avatar
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    Still wondering how long that could take - approval by the FDA?
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  3. #3
    Super Moderator Sue Pendleton's Avatar
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    Because 4-aminopyridine was left on the compounding formula for so long my guess is Fampridine will get a thumbs up fairly fast. I mean by making it timed release it reduces almost all the side effects like insomnia, tingling, and especially the chance of seizures but that is up to what kind and where a person has MS lesions.

    I know I'll be at the pharmacy as soon as it is approved!

    Quote Originally Posted by lynnifer
    Still wondering how long that could take - approval by the FDA?
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  4. #4
    Cant wait It will save me 80 dollars a month but it is worth every penny anty
    Be always determined in Life and Love

  5. #5
    I should be on the phone tomorrow and I will find out if I have permission to post any new updates. I was told that the goal was to eventually take us up to 80 mg but the SCI clinical trials came to an abrupt end. I had good results and I think after the first month I was up to 50 mg with absolutely no side effects.

    Sue, thanks and I hope you feel better real soon before you get on that cruise ship.

  6. #6
    Super Moderator Sue Pendleton's Avatar
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    Quote Originally Posted by PN
    I should be on the phone tomorrow and I will find out if I have permission to post any new updates. I was told that the goal was to eventually take us up to 80 mg but the SCI clinical trials came to an abrupt end. I had good results and I think after the first month I was up to 50 mg with absolutely no side effects.

    Sue, thanks and I hope you feel better real soon before you get on that cruise ship.
    I haven't heard anything more on Fampridine. If anyone else does please post! And my apologies. I should have left a note before going on a 20 day vacation so soon after leaving the forum stranded while I experienced the thrills of my first kidney infection. Waking up to a fever of 105, an ambulance and then 5 days in the hospital sort of sucks if any of you are thinking about it. Many thanks to those who answered others questions and stepped in for me.

    Oh, and almost 2 months after the end of the IV antibiotics and before I started the orals I still feel tired a lot. It is amazing how long a high white count and fever can effect us. So remember flu shots and pnuemonia vaccines if you haven't had them already. The Pnuemova is suggested every 5 years for people with SCI/TM. Both are covered by Medicare.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  7. #7
    I am wondering when the FDA will approve Acorda's Fampridine? Has anyone heard anything more about it?

    Thanks!

  8. #8
    Quote Originally Posted by LFC
    I am wondering when the FDA will approve Acorda's Fampridine? Has anyone heard anything more about it?

    Thanks!
    The FDA required a second phase 3 and this is what Acorda Therapeutics is doing. Wise.

  9. #9
    Does that mean they didn't find the results of the first phase three trial reliable? How long will another phase three trial take, and if the results are to the FDA's satisfaction, will approval follow soon after? My son has taken the formulated 4AP for over three years, and we are hoping the "real' stuff will be available soon.

    Thanks again!

  10. #10
    Quote Originally Posted by LFC
    Does that mean they didn't find the results of the first phase three trial reliable? How long will another phase three trial take, and if the results are to the FDA's satisfaction, will approval follow soon after? My son has taken the formulated 4AP for over three years, and we are hoping the "real' stuff will be available soon.

    Thanks again!
    The FDA usually requires two phase 3 studies with positive results before they will approve a treatment. So, Acorda is doing the second trial. It should be completed by the end of 2007. If the trial shows results that meets criteria, the drug will be approved.

    Wise.

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