Phase 3 Study of Dificid for Clostridium difficile infection

Optimer Pharmaceuticals announced the presentation of two analyses of its Phase 3 study of Dificid (fidaxomicin) for the treatment of Clostridium difficile infection (CDI). The first analysis aimed to identify risk factors associated with early recurrence (a relapse within the first two weeks after end of therapy) compared to late recurrence (a relapse during the third and fourth weeks after end of therapy). Data demonstrated that the majority of recurrences occurred within two weeks of completing initial therapy (129/190, 67.9%). Treatment with Dificid was associated with a 66% reduction of early recurrence compared with vancomycin (7.4% vs. 19.3%, P<0.001), and late recurrence was the same in both treatment arms. The second analysis demonstrated that Dificid is minimally absorbed with plasma levels in the low ng/mL range while maintaining high fecal concentrations that are well in excess of the MIC90 vs. C. difficile.

Dificid is an antibiotic for the treatment of Clostridium difficile infection.

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