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Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
Date:10/23/2010

4/518)

< 0.001

(6.7, 17.6)modified Intent-to-Treat
(mITT)Fidaxomicin
(200mg bid)Vancocin® capsules
(125mg qid)p-value95% Confidence IntervalClinical Cure87.9% (474/539 patients)

86.2% (488/566 patients)

NA

(-2.3, 5.7)Recurrence14.1% (67/474)

26.0% (127/488)

< 0.001

(-16.8, -6.8)Global Cure75.5% (407/539)

63.8% (361/566)

< 0.001

(6.3, 17.0)NA= Not Applicable (trial met non-inferiority endpoint)The Per Protocol (Microbiologically Evaluable) Population is the patient group with CDI confirmed by diarrhea with a positive toxin assay, met all inclusion/exclusion criteria, and received at least 3 days of therapy and were considered a failure or at least 8 days of therapy and were considered a cure.The Modified Intent-to-Treat Population is the patient group with CDI confirmed by diarrhea  with a positive toxin assay and received at least one dose of study medication."The combined data set of more than 1,100 patients show that fidaxomicin is statistically superior in preventing recurrences and achieving global cures compared to vancomycin.  Fidaxomicin as a single agent offers potential advantages over existing therapies," said Dr. Crook, Consultant Microbiology/Infectious Diseases and Professor of Infectious Diseases and Microbiology, Experimental Medicine Division, Nuffield Department of Clinical Medicine (NDM), University of Oxford.  

For a complete list of abstracts, please visit the Resources page on our website: www.optimerpharma.com

Fidaxomicin Clinical StudiesThe two fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult subjects.  Subjects with confirmed CDI received either fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h), the only FDA approved product for the treatm
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SOURCE Optimer Pharmaceuticals, Inc.
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