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Ironwood Presents New Data on Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old at Digestive Disease Week® 2023
– Additional data presentations further characterize the efficacy and safety profiles of linaclotide in this patient population – – Functional constipation
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Additional data presentations further characterize the efficacy and safety profiles of linaclotide in this patient population –\n\n\n– Functional constipation affects an estimated 6 million 6-17 year-olds in the U.S.1; there are currently no FDA-approved prescription therapies –\n\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, presented findings during the 2023 Digestive Disease Week® (DDW) meeting from a Phase III clinical trial on the potential of linaclotide for children and adolescents ages 6-17 years-old with functional constipation. Ironwood had previously announced topline data from this study in September 2022.\n\n\nThe presented data at DDW, which provided a more detailed description of the trial results, were announced during an oral presentation titled Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients Aged 6-17 Years: A Phase 3, Pivotal, Randomized, Placebo-Controlled Trial (presentation number 145), which highlighted that linaclotide 72 mcg met primary and secondary endpoints for increased frequency of spontaneous bowel movements (SBM) and improvement in stool consistency in this patient population. Linaclotide was generally well-tolerated and exhibited a safety profile consistent with a prior pediatric Phase II study in functional constipation.\n\n\nFunctional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass2. The condition affects an estimated 6 million children ages 6-17 years-old in the U.S.1\n\n\n“Functional constipation is one of the most common complaints patients bring to their pediatricians and pediatric gastroenterologists, yet we have no approved prescription therapies to offer to our young patients,” said Jeffrey S. Hyams, M.D., Head, Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children’s Medical Center, Professor of Pediatrics, University of Connecticut School of Medicine. “These results are significant because they show the potential of linaclotide in addressing bothersome symptoms for patients ages 6-17 years-old with this condition.”\n\n\nIn this pivotal study, linaclotide showed a statistically significant and clinically meaningful improvement compared to placebo in 12-week SBM fre...