H. pylori treatment regimens should achieve 70% minimum cure rate -- FDA draft guidance.

Executive Summary

H. PYLORI REGIMENS SHOULD ACHIEVE MINIMUM CURE RATE OF 70%, FDA recommends in its draft guidance to industry on "Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products." The draft states that "the minimum number of patients recommended in a [Helicobacter pylori] study would be 178 if the mean cure rate is 70% and the lower 95% confidence limit is 60%." An advisory committee meeting to discuss the draft guidance has been scheduled for March 5-7 ("The Pink Sheet" Feb. 17, In Brief).