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Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced The New England Journal of Medicine has published results from the North American Phase 3 trial evaluating the safety and efficacy of the Company’s novel antibiotic fidaxomicin as a treatment for patients with Clostridium difficile infection (CDI). The Phase 3 trial showed that fidaxomicin significantly reduced recurrence rates and increased global cure rates when compared to vancomycin, the only treatment approved by the U.S. Food and Drug Administration for CDI. The article titled,
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Added: 5065 days ago by MultiVuVideo
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Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s antibacterial drug DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (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 people previously at low risk for the disease. In the largest Phase 3 clinical studies ever conducted in CDAD, DIFICID had clinical response rates at the end 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. To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/optimerpharma/50177/
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Added: 4957 days ago by MultiVuVideo
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