Home News Linzess safely improves bowel movement, consistency in pediatric functional constipation

Linzess safely improves bowel movement, consistency in pediatric functional constipation

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September 24, 2022

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Ironwood Pharmaceuticals Inc. announced positive results from its phase 3 trial that evaluated Linzess for the treatment of pediatric patients with functional constipation, according to a company press release.

In a randomized, double-blind, parallel group study, 330 pediatric patients with functional constipation aged 6 to 17 years received either Linzess (linaclotide 72 mcg, AbbVie/Ironwood) or placebo. In a Healio interview exclusive, Susanna Huh, MD, MPH, head of clinical development and research for Ironwood Pharmaceuticals, said Linzess induced a “statistically significant and clinically meaningful improvement compared with placebo in 12-week spontaneous bowel movement frequency,” and a greater than two-fold least squares mean change from baseline per week compared with placebo. Researchers also observed improved stool consistency.

Susanna Huh quote

Linzess was safe and well tolerated; diarrhea was the most frequent treatment-emergent adverse event which occurred in 4.3% of patients taking Linzess vs. 1.8% of those on placebo. It is indicated for the treatment of adult patients with irritable bowel syndrome-constipation as well as chronic idiopathic constipation and is not yet approved for patients aged younger than 18 years.

“Functional constipation is highly prevalent in pediatric patients, affecting an estimated 4 million to 6 million children ages 6 to 17 in the United States, yet there are no FDA-approved prescription treatments for children,” Huh said. “We are excited by the strong results of this phase 3 trial and are focused on working with our partner, AbbVie, to evaluate a potential supplemental new drug application submission.”

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