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Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
Date:5/17/2009

i> was present in 36% of patients in the study. 46% of the patients were over the age of 65, 56% were in-patients, 17% had a prior episode of CDI and study participants had an average of 8.3 bowel movements per day.

The incidence of adverse events and serious adverse events between the fidaxomicin and Vancocin arms was similar.

Additional detailed data from the study will be presented at medical conferences throughout the year.

Fidaxomicin Clinical Study Design

629 adult subjects were enrolled in this multi-center, randomized, double-blind Phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI.

The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator. The secondary endpoint evaluated CDI recurrence up to four weeks post therapy with recurrence defined as the return of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients who were cured and did not have a recurrence.

About Clostridium Difficile Infection

CDI has become a growing problem in hospitals, long-term care facilities and in the community. It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe d
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SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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