WASHINGTON, D.C. ( TheStreet) -- Optimer Pharmaceuticals (OPTR) brings its antibiotic fidamoxicin in front of a U.S. Food and Drug Administration advisory panel today, seeking a positive recommendation that could lead to the drug's approval in May.
Fidamoxicin is being developed as a new treatment for Clostridium difficile infection (CDI), a serious bacterial illness that infects the lining of the colon and causes severe abdominal pain, bloating and diarrhea. In severe cases, CDI can result in ruptured colons, cause blood infections and lead to death.
A review of fidamoxicin by FDA regulators posted Friday agreed with Optimer's data demonstrating the drug to be as effective as Viropharma's (VPHM) Vancocin in curing CDI. Fidamoxicin also reduced the percentage of patients who relapsed by half compared to patients treated with Vancocin.Optimer's fidamoxicin is a novel, narrow-spectrum antibiotic that is designed to target C. diff. bacteria with a more convenient twice-daily dosing schedule.
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