Linzess safely improves bowel movement, consistency in pediatric functional constipation
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.
Linzess was safe and well tolerated among 328 patients who received the study treatment; 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.”