Ironwood announces publication of Phase III study in The Lancet

Ironwood Pharmaceuticals announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology. The data highlights additional efficacy endpoints from the company’s pivotal Phase III trial, which formed the basis of the June 2023 U.S. Food and Drug Administration approval of linaclotide for the treatment of functional constipation in this population. Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass. The condition affects an estimated 6 million children aged 6-17 years in the U.S. “Functional constipation is among the most common complaints pediatricians and pediatric GIs see in our patients,” said Miguel Saps, Chief of Division of Pediatric Gastroenterology, Hepatology, and Nutrition and the George E. Batchelor Endowed Chair in Pediatrics, University of Miami, University of Miami Health System. “The insights provided by the additional efficacy endpoints in this Phase III clinical trial are an important supplement to clinicians’ knowledge about the available treatment options for this population.”