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Ironwood Announces Publication in The Lancet Gastroenterology & Hepatology of New Linaclotide Phase III Data in Children and Adolescents Aged 6-17 Years with Functional Constipation
– Newly published data highlights additional efficacy endpoints from trial – – Linaclotide is the first and only FDA-approved prescription therapy for
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Newly published data highlights additional efficacy endpoints from trial –\n\n\n– Linaclotide is the first and only FDA-approved prescription therapy for children and adolescents aged 6-17 years with functional constipation –\n\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today 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 (FDA) approval of linaclotide for the treatment of functional constipation in this population.\n\n\nFunctional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass1. The condition affects an estimated 6 million children aged 6-17 years in the U.S.2\n\n\n“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.”\n\n\nIn this peer-reviewed pivotal study, a total of 328 patients received the study treatment, randomized (1:1) to either linaclotide 72 mcg or placebo. Linaclotide demonstrated a statistically significant and clinically meaningful improvement compared to placebo in 12-week spontaneous bowel movement(s) (SBM) frequency rate (SBMs/week), the primary endpoint. A statistically significant proportion of linaclotide-treated patients achieved a greater than two-fold least squares mean change from baseline in SBMs/week (2.220) compared to placebo (1.050) (p","length":2948,"tagName":"div"}]