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Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
Date:1/24/2011

s our goal of helping patients who are suffering from this disease." 

The NDA is supported by data from the two largest comparative Phase 3 clinical trials ever conducted against vancomycin in CDI. The two fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult patients. Patients with confirmed CDI received either fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h), the only FDA approved product for the treatment of CDI. In both of these studies, fidaxomicin met the primary endpoint of non-inferiority of clinical cure compared to Vancocin. Importantly, in both trials fidaxomicin was statistically superior to Vancocin in reducing recurrences of CDI and in global cure rate.

About Clostridium difficile Infection (CDI)Clostridium difficile infection (CDI), commonly referred to as "C. difficile" or "c-diff", has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S.  It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death.  Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.

Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment.  However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.

Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and
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SOURCE Optimer Pharmaceuticals, Inc.
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