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Optimer Announces that the U.S. Food and Drug Administration's Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificid™ for Treatment of Patients with Clostridium difficile infection (CDI)
Date:4/5/2011

effective as vancomycin in clinical cure, and was superior to vancomycin in global cure, defined as cure without a recurrence after 4 weeks of therapy. The advisory committee referred to the global cure outcome as 30-day resolution, which we believe is indicative of DIFICID's benefit in reducing recurrences," said Sherwood Gorbach, M.D., Optimer's Chief Medical Officer. "While the advisory committee vote was split on how best to describe the recurrence benefit, the committee members overwhelmingly recognized that DIFICID at 30 days was superior to vancomycin. We appreciated the committee's discussion and look forward to working with the FDA as it considers our DIFICID NDA."

The AIDAC based its decision in part on the review of clinical evidence from the two largest, comparative Phase 3 clinical trials ever conducted against vancomycin in CDI. These multi-center, randomized, double-blind trials enrolled a total of 1,164 adults with confirmed CDI, who received either DIFICID (200 mg q12h) or vancomycin (125 mg q6h), the only FDA-approved product for the treatment of CDI. The objective of both studies was to show that a 10-day course of DIFICID was at least as efficacious (non-inferior) and safe as a 10-day course of vancomycin for the treatment of CDI. In both studies, DIFICID demonstrated a statistically significant reduction in the rate of recurrence compared with patients treated with vancomycin, reducing CDI recurrences by 47 percent, and was statistically superior to vancomycin in global cure rate (clinical cure without disease recurrence within four weeks). In addition, DIFICID met the primary endpoint of non-inferiority of clinical cure (defined as patients requiring no further CDI therapy two days after completion of study medication) compared to vancomycin.

DIFICID was safe and well tolerated in both studies, showing a similar incidence of treatment-related adverse events when compared to vancomycin.

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