The US Food and Drug Administration approved linaclotide (LINZESS) for pediatric patients aged 2 years and older with functional constipation, expanding the indication to include children aged 2 to 5 years, according to a press release from Ironwood Pharmaceuticals. Linaclotide was previously approved for pediatric patients aged 6 years and older with functional constipation and remains the only FDA-approved prescription therapy for pediatric functional constipation.

Functional constipation is characterized by infrequent, hard, and painful bowel movements and commonly affects preschool-aged children. According to the company, the estimated worldwide prevalence among preschool-aged pediatric patients is approximately 3%.

The approval was supported by findings from a 12-week phase 3 randomized placebo-controlled trial evaluating linaclotide 72 mcg in patients aged 2 to 5 years with functional constipation. Researchers reported that linaclotide improved spontaneous bowel movement frequency compared with placebo. The safety profile observed in the trial was generally consistent with previous studies in adults with chronic idiopathic constipation and older pediatric patients with functional constipation.

In the press release, pediatric gastroenterologist Julie Khlevner, MD, of Columbia University Vagelos College of Physicians and Surgeons, stated: “Managing functional constipation in young children is especially challenging, as this vulnerable patient population often continues to experience persistent symptoms despite treatment with over-the-counter therapies.” She continued, “The availability of an FDA-approved therapy with an established safety profile expands evidence-based treatment options and may support a more tailored therapeutic approach for children aged 2-5 years. Parents can mix the contents of the LINZESS capsule with applesauce or water, providing flexibility for administration in young children.”

Linaclotide is a guanylate cyclase-C agonist indicated for irritable bowel syndrome with constipation in adults and pediatric patients aged 7 years and older, chronic idiopathic constipation in adults, and functional constipation in pediatric patients aged 2 years and older.

The prescribing information includes a boxed warning stating that linaclotide is contraindicated in patients younger than 2 years because of the risk of serious dehydration. Diarrhea was the most commonly reported adverse reaction in adult and pediatric clinical trials.

Source: Ironwood Pharmaceuticals