The FDA has approved linaclotide (Linzess) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation, according to a Nov. 5 news release.
Linzess is the first treatment approved for this condition in pediatric patients.
The approval was supported by adult efficacy data and a 12-week trial in patients seven- to 17-years-old who met criteria for pediatric IBS-C. Patients needed to show at least a 30% reduction in abdominal pain and at least two additional spontaneous bowel movements per week for at least six of the 12 weeks.
The safety profile in pediatric patients was similar to that seen in adults. Diarrhea was the most commonly reported side effect. The FDA advised discontinuation and rehydration in cases of severe diarrhea.
