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Optimer Pharmaceuticals, AŞ Message Board

  • californialots californialots May 31, 2011 12:27 PM Flag

    optr news

    Optimer's Dificid Approved in US

    Companies:Cubist Pharmaceuticals Inc.Optimer Pharmaceuticals, Inc.ViroPharma Inc.
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    Zacks Equity Research, On Tuesday May 31, 2011, 9:30 am EDT
    Optimer Pharmaceuticals Inc. (NasdaqGM: OPTR - News) received a huge boost recently when it received approval from the US Food and Drug Administration (FDA) for its first drug, antibiotic Dificid, for the treatment of clostridium difficile-associated diarrhea (CDAD). CDAD is the most common nosocomial or hospital-acquired diarrhea and is a significant malaise in hospitals and nursing home facilities. Optimer's Dificid twice daily tablets are the first drug to be approved in almost 30 years for the treatment of CDAD.

    The FDA approval was based on combined data from two of the largest late-stage studies ever conducted for the disease. Data revealed that Dificid was non-inferior to ViroPharma’s (NasdaqGS: VPHM - News) Vancocin (the only FDA approved antibiotic for the treatment of clostridium difficile infection) in achieving clinical response at the end of treatment. In addition, data further showed the superiority of Dificid over Vancocin in sustaining clinical response through 25 days post treatment. Dificid thus becomes the only drug which has shown superiority over Vancocin in sustained clinical response for CDAD. The drug is also under regulatory review in the EU.