The US Food and Drug Administration approved linaclotide (Linzess) capsules for children aged 7 years and older with irritable bowel syndrome with constipation, making it the first FDA-approved treatment for this condition in pediatric patients. Irritable bowel syndrome with constipation (IBS-C) is a chronic gastrointestinal disorder marked by infrequent, hard, or painful stools, abdominal pain, and bloating. The condition has no identifiable organic cause and is thought to arise from multiple contributing factors.

Approval was based on efficacy data extrapolated from adults with IBS-C, supported by a 12-week, double-blind, randomized, parallel-group trial in 7- to 17-year-olds who met modified Rome III criteria for IBS-C. The primary endpoint was the proportion of patients achieving both at least a 30% reduction in abdominal pain and an increase of at least two spontaneous bowel movements per week from baseline for 6 or more of the 12 treatment weeks. Results in children were consistent with those observed in adults, demonstrating similar clinical benefits.

The safety profile of linaclotide in pediatric patients mirrored that seen in adults. Diarrhea was the most frequently reported adverse event. The FDA advises discontinuation and rehydration if severe diarrhea occurs. Because of the risk of serious dehydration, linaclotide should not be used in patients younger than 2 years or in those with known or suspected mechanical gastrointestinal obstruction.

The recommended dosage for pediatric patients aged 7 years and older with IBS-C is 145 mcg taken orally once daily.

Source: FDA