WASHINGTON, D.C. (
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
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. [Vancocin, must be taken four times a day.] Fidamoxicin remains largely in the gut, reducing systemic exposure, and limits the disturbance of normally occurring, beneficial bacteria.
Tuesday's advisory panel will review the fidamoxixin data and vote on whether or not to recommend the drug's approval. FDA is expected to issue an approval decision by May 30.
Optimer shares closed Monday up 5% to $13.80.
--Written by Adam Feuerstein in Boston.
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