The FDA approved Ironwood Pharmaceuticals' Linzess (linaclotide) capsules June 12, making it the first pediatric treatment for functional constipation.
There are no known causes and usually multiple factors leading to the common condition that makes stools hard and difficult to pass, according to the FDA. Linzess was approved in 2012 for adult patients with constipation, and more than 10 years later, it's approved for patients between 6 and 17 years old.
In a phase 3 trial, pediatric patients who took Linzess had more spontaneous bowel movements than those who took the placebo after 12 weeks. In the study, 4 percent of Linzess patients experienced diarrhea, which was the most common side effect.