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Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
Date:10/23/2010

ent 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.  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 recurrence rate, reducing CDI recurrences by 47% and in global cure rate. Fidaxomicin was well tolerated in both studies.

About FidaxomicinFidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in rapid killing of C. difficile. The narrow-spectrum profile of fidaxomicin eradicates C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, seriously disrupt the flora. Fidaxomicin facilitates the early return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence.

About Clostridium difficile Infection (CDI)Clostridium difficile infection (CDI), commonly referred to as 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 caused by infection of the inner lining of the colon by C. difficile bacteria, which produces toxins that cau
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SOURCE Optimer Pharmaceuticals, Inc.
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