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Thread: 4-ap

  1. #1


    4-ap approved -- just heard on CNBC

  2. #2
    Senior Member kate's Avatar
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    bellevue, wa, usa



  3. #3
    So anybody know how long it will take to actually get it? What's the ramp-up time to manufacture it and distribute it to pharmacies?

    I'm calling my doctor this afternoon to see about getting a scrip.

  4. #4
    Just found the answer to my question here:

    It's going to probably be a few months to get it. I tried the compounding formula a few years ago. It definitely helped me, but it gave me such bad indigestion and heartburn that I couldn't stand it. I understand that Acorda's formulation is supposed to be better regarding that side effect. I hope that's true.
    Last edited by bruce; 01-22-2010 at 05:33 PM.

  5. #5
    Senior Member
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    Fithian, IL
    Wonderful news. According to Acorda's page it should be available in March!!!

  6. #6
    FDA Clears Acorda Drug for Multiple Sclerosis
    FDA approves Ampyra as first drug to aid walking in multiple sclerosis patients

    By MATTHEW PERRONE AP Business Writer
    WASHINGTON January 22, 2010 (AP)

    Federal health regulators have approved an Acorda Therapeutics pill to improve walking in patients multiple sclerosis, an often disabling disease that affects the nervous system.

    The Food and Drug Administration said Friday Ampyra is the first drug approved to help multiple sclerosis patients walk.

    About 400,000 patients in the U.S. have the disease, which affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems.

    Between 260,000 and 340,000 of those patients have difficulty walking, and could be eligible for the new drug, according to company officials.

    Acorda, based in Hawthorne, N.Y., conducted two trials tracking patients' ability to complete a 25-foot walking exercise. Both studies showed improvements in time needed to complete the exercise. While those gains were often just a fraction of a second, Acorda CEO Ron White said that on average, patients' times improved by 25 percent after taking Ampyra...

    Drug to Aid MS Patients Wins Approval


    WASHINGTON—The Food and Drug Administration Friday approved a new drug from Acorda Therapeutics Inc. to improve walking in patients with multiple sclerosis.

    The FDA said the drug, Ampyra, is the first drug approved to improve walking in MS patients.

    The agency said clinical trials showed patients treated with Ampyra had faster walking speeds than those treated with a placebo, or fake pill.

    Multiple sclerosis is a progressive disease that involves damage to nerves controlling muscles and vision; it affects about 400,000 Americans. The condition causes the body's immune system to eat away at the protective covering of the nerves, or myelin, which disrupts the electrical signals between the brain and the rest of the body.

    Ampyra is designed to help the body's electric signals pass through by blocking potassium ions that leak from the damaged nerves.

    The FDA said the product will be manufactured under licenses from Dublin-based Elan Corp. PLC and distributed by Acorda, Hawthorne, N.Y. Acord shares were up 9.8% at $28.12 in 4 p.m. trading Friday on the Nasdaq Stock Market.

    The FDA said the drug can cause seizures when given at higher than the recommended dose of 10 milligrams twice a day and shouldn't be used in patients with moderate to severe kidney disease.

    In October an outside panel of medical experts backed the drug, saying it appeared to be safe and effective...
    Last edited by antiquity; 01-22-2010 at 06:58 PM.

  7. #7

    Acorda Therapeutics Receives Marketing Approval From FDA For AMPYRA - Quick Facts
    1/22/2010 5:04 PM ET

    (RTTNews) - Acorda Therapeutics Inc. (ACOR: News ) announced that it has received marketing approval from the U.S. FDA for AMPYRA, an oral treatment to improve walking in patients with multiple sclerosis. The company stated that AMPYRA demonstrated efficacy in people with all four major types of multiple sclerosis; relapsing remitting, secondary progressive, progressive relapsing and primary progressive. AMPYRA can be used alone or with existing multiple sclerosis therapies, including immunomodulator drugs.

    AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine, which was previously called fampridine. The FDA granted AMPYRA orphan drug status, which will provide seven years of market exclusivity for the drug.

    The FDA approved AMPYRA with a risk evaluation and mitigation strategy program comprising a medication guide and communication plan. The goals of the communication plan are to inform patients about the serious risks, including seizures, associated with use of higher than recommended doses of AMPYRA therapy, and the change of the established name from fampridine to dalfampridine.

  8. #8

    What does the cashflow that will come from this drug mean for the development of Acorda's other SCI-focused treatments?

  9. #9
    Obviously wonderful news !!!

    Any idea when Acorda may actually start U.S. distribution?

  10. #10
    Senior Member
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    Fithian, IL
    Quote Originally Posted by AHerzlich View Post
    Obviously wonderful news !!!

    Any idea when Acorda may actually start U.S. distribution?

    March 2010

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