Ironwood Pharmaceuticals, Inc. 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 2023Food and Drug Administration (FDA) approval of linaclotide for the treatment of functional constipation in this pediatric 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 and adolescents ages 6-17 years-old in the U.S. The 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 % 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%), and fewer children treated with linaclotide (15.2%) experienced an increase in rescue medication use compared to those treated with placebo (26.2 percent; p=0.0095). Ironwood and its collaborators will present additional data describing the cumulative treatment effect of linaclotide in this patient population.

Additionally, Ironwood and its partner AbbVie are sponsoring a medical symposium titled ?Managing Pediatric Constipation? on Oct. 6, 2023 from 6:00 to 8:00 p.m. PDT (Room: Indigo AE).

The symposium, which is not an official NASPGHAN event/function, will provide meeting attendees with an overview of pediatric functional constipation, presentation/diagnosis and management. Cumulative Effect of Linaclotide in Children and Adolescents Ages 6-17 Years-Old with Functional Constipation A poster titled Cumulative Treatment Effect of Linaclotide for Pediatric Functional Constipation: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (presentation number 729) will be presented on Oct. 7, 2023 from 12:30 to 1:30 p.m. PDT in the Sapphire Ballroom by Tina Shakhnovich, M.D. The analysis showed that a higher proportion of patients in the linaclotide treatment group versus the placebo consistently achieved improvement at every responder threshold for increase in spontaneous bowel movement frequency and achievement of softer post-baseline stool consistency.

A poster titled Cumulative Experience with Diarrhea as an Uncommon Treatment-Emergent Adverse Event in Pediatric Trials of Linaclotide for the Treatment of Functional Constipation (presentation number 727) will be presented on Oct. 7, 2023, from 12:30 to 1:30 p.m. PDT in the Sapphire Ballroom by Julie Khlevner, M.D., Columbia University Vagelos College of Physicians and Surgeons and New York Presbyterian Morgan Stanley Children?s Hospital, New York, NY. The post-hoc analysis demonstrated that in pediatric patients with functional constipation, diarrhea occurred in 7.4 percent of the linaclotide-treated population and 1.5 percent of those receiving placebo.