Why did FDA approve Lotronex in the first place?
The FDA based its approval of Lotronex on the results of two, 12-week double-blinded, placebo-controlled clinical trials. A total of 1273 non-constipated women, who met specific pain and stool consistency criteria, were enrolled. In each study, Lotronex was significantly more effective than the placebo in providing relief from IBS pain and discomfort and in reducing the percentage of days with urgency. Treatment with Lotronex also resulted in firmer stools and a significant decrease in stool frequency.
