FDA Approves New Antibiotic for Treatment of Clostridium Difficile Infections

May 30, 2011

C. difficile bacteria. Photo credit: CDC

The Food and Drug Administration (FDA) has approved a new antibiotic used to treat intestinal tract infections caused by Clostridium difficile. Optimer Pharmaceuticals Inc. announced the FDA approval of the drug on May 27, 2011.

About Clostridium difficile Infection (CDI)

Clostridium difficile infection (CDI), commony referred to as “C. difficile” or “c-diff”, has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S. It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.

CDI is recognized as a serious diarrheal illness. It is associated with substantial rates of morbidity and mortality.

About Dificid™

The antibiotic, called Dificid™, generically known as fidaxomicin, is a tablet that is administered twice-a-day.   Fidaxomicin is a narrow spectrum antibiotic specifically developed for the treatment of CDI.

In company trials, Dificid™ worked as well as vancomycin for treating CDI.  It proved to be superior at preventing re-infections as compared to vancomycin. There is a significantly lower rate of recurrence of CDI when treated with fidaxomicin.

Dificid™ is the Optimer Pharmaceutical Inc.’s first FDA-approved product.

Prior to the FDA approval of Fidaxomicin, vancomycin was the only FDA approved product for CDI.

Prior treatment for CDI was oral vancomycin or metronidazole. The rate of recurrence of infection with these treatments is high however.

In two Phase 3 clinical trials for CDI treatment, fidaxomicin was shown to be equally effective for curing CDI as compared to vancomycin treatment. In addition, after treatment with fidaxomicin, the risk of recurrence of the infection was 47% compared to vancomycin. The results of the Phase 3 trials were presented in the February 3, 2011 issue of the New England Journal of Medicine, “Fidaxomicin versus Vancomycin for Clostridium difficile Infection.”

References:

Trading Halted Today in Optimer Pharmaceuticals Stock. Optimer Pharmaceuticals, Inc.

Optimer Pharmaceuticals, Inc. FDA Approves Optimer’s Dificid™ (fidaxomicin) Tablets for the Treatment of Patients with Clostridium difficile-Associated Diarrhea (CDAD). May 27, 2011.

Pollack, A. F.D.A. Approves Drug to Treat Hospital Scourge. The New York Times. May 28, 2011, p. B1.

Louie, T.J., Miller, M.A., Mullane, K.M., et al. Fidaxomicin versus Vancomycin for Clostridium difficile Infection. New England Journal of Medicine, 364:422-431 (2011).

Prescribing Information for Dificid™.

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