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Optimer releases fidaxomicin Phase 3 trial results

San Diego-based Optimer Pharmaceuticals, a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections, has released the results from the its North American Phase 3 trial of fidaxomicin to treat Clostridium difficile infections (CDI).

Optimer said fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the rapid killing of C difficile.

The aim of the multi-center, randomized, double-blind clinical trial was to evaluate the safety and efficacy of the company’s novel antibiotic fidaxomicin as a treatment for patients with CDI.

Results have shown that fidaxomicin significantly reduces recurrence rates and increased global cure rates when compared to vancomycin – the only treatment approved by the US Food and Drug Administration for CDI.

The article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection," appears in the 3 February, 2011 issue of The New England Journal of Medicine journal.