Optimer's DIFICIDÂ® (fidaxomicin) Tablets Approved By Health Canada For The Treatment Of Clostridium Difficile Infection And Now Available To Canadian Patients
SAN DIEGO, July 5, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that DIFICID® (fidaxomicin) tablets were approved by Health Canada for the treatment of Clostridium difficile infection (CDI), in adults 18 years of age and older and that DIFICID is now available to treat patients in Canada. The approval was based on Health Canada's evaluation of two large, multi-national, Phase 3 clinical trials demonstrating that DIFICID was as effective as oral vancomycin in providing an initial clinical response and was superior in providing a sustained clinical response for 28 days post treatment. DIFICID is the first new treatment for CDI to be approved in Canada in over 20 years.
"Clostridium difficile infections have been an increasing challenge and burden for the Canadian health care system during the last decade and affect the elderly population in a disproportionate manner," said Dr. Karl Weiss Professor of Medicine Maisonneuve-Rosemont Hospital, Faculty of Medicine, Universite de Montreal. "Reducing CDI recurrence is a major objective knowing that 20% to 30% of affected Canadian patients will experience at least one relapse of the disease, escalating over 60% after multiple recurrences."
The Health Canada product monograph for DIFICID highlights some of the important features of the product, including:
- Narrow spectrum activity that is bactericidal against C. difficile in vitro
- Mainly confined to the gastrointestinal tract
- Minimal effect on intestinal flora, with studies having demonstrated that fidaxomicin treatment did not affect Bacteroides concentrations or other major components of the microbiota in the feces of CDI patients
- Shown to inhibit C. difficile sporulation in vitro
- Suppresses the production of both toxin A and toxin B and inhibits toxin gene expression in vitro
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