DIFICID FDA Approval
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) declared today that the U.S. Food and Tablets Administration (FDA) has approved the company’s antibacterial drug DIFICID™ (fidaxomicin) tablets all for the treatment of Clostridium difficile-associated diarrhoea (CDAD) in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and is beginning to emerge in the community among group previously at poor risk for the disease. In the largest Phase 3 clinical studies ever conducted within CDAD, DIFICID had clinical response rates at the failure of treatment that were non-inferior to oral vancomycin. DIFICID was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment. DIFICID is the only FDA-approved antibacterial drug proven to be superior to vancomycin in sustained clinical response for CDAD.
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