The U.S. Food and Drug Administration approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years with functional constipation.
The approval was based on data from 328 participants who were randomly assigned (1:1) to receive Linzess or placebo. A statistically significant benefit and clinically meaningful improvement was seen for 12-week spontaneous bowel movement frequency rate with Linzess compared with placebo, with Linzess-treated patients showing a greater than twofold least squares mean change from baseline in spontaneous bowel movements per week (2.6 versus 1.3). Diarrhea was the most common adverse event reported (4 percent of Linzess-treated patients versus 2 percent of placebo-treated patients).
