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Ironwood to Present New Data at NASPGHAN Annual Meeting Reinforcing Impact of Linaclotide on Functional Constipation in Children and Adolescents Ages 6-17 Years-Old
– Data demonstrates that linaclotide reduces the need for rescue medications in this patient population – – Additional presentations further characterize the
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Data demonstrates that linaclotide reduces the need for rescue medications in this patient population –\n\n\n– Additional presentations further characterize the efficacy and safety profiles of linaclotide as the only FDA-approved prescription therapy for this patient population –\n\n\n– Functional constipation affects an estimated 6 million children and adolescents ages 6-17 years-old in the U.S.1 –\n\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a leading global gastrointestinal healthcare company, will present findings during the 2023 North American Society for Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) Annual Meeting demonstrating that linaclotide decreased the use of rescue medications in children and adolescents ages 6-17 years-old with functional constipation. These findings build on previously announced data from the company’s pivotal Phase III trial, which formed the basis of a June 2023 Food and Drug Administration (FDA) approval of linaclotide for the treatment of functional constipation in this pediatric population.\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 and adolescents ages 6-17 years-old in the U.S.1\n\n\nThe data, which were part of a post-hoc analysis, will be featured in a poster titled Once-Daily Linaclotide 72 µg Reduces the Need for Rescue Medication Use in Children with Functional Constipation (presentation number 465) on Oct. 6 from 12:30 to 1:30 p.m. PDT in the Sapphire Ballroom presented by Tina Shakhnovich, M.D., pediatric gastroenterologist and Ironwood’s Medical Director of Clinical Development. The analysis found that approximately half of the children enrolled in the trial relied on rescue medications at least once per week for symptom relief. By the end of the 12-week treatment period, the use of rescue medications, which included senna (oral), bisacodyl (oral or rectal) or sodium picosulphate (oral), decreased to 8.7 percent of children receiving linaclotide versus 18.8 percent of children receiving placebo. Over the entire study period, more children treated with linaclotide (61.0 percent) experienced a decrease in rescue medication use compared to those treated with placebo (48.2...