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Fidaxomicin Clinical StudiesThe two fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult subjects. Subjects with confirmed CDI received either fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h), the only FDA approved product for the treatment of CDI. These studies were designed to evaluate safety and compare the response to treatment in subjects during and after a 10-day course of therapy. The primary endpoint was non-inferiority compared to Vancocin in clinical cure (defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator). If cured, subjects were monitored for a subsequent four-week period to evaluate recurrence, which was a secondary endpoint. Global cure, also a secondary endpoint, was defined as patients who were cured and did not have a recurrence during this subsequent four-week period. In both of these studies, fidaxomicin achieved its primary endpoint of non-inferiority compared to Vancocin. Fidaxomicin was also statistically superior to Vancocin in global cure rate and in reducing recurrences of CDI.
About Clostridium difficile Infecti
|SOURCE Optimer Pharmaceuticals, Inc.|
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