\u2013 Pivotal Phase III data will be spotlighted via an oral presentation \u2013<\/i><\/p>\n
\u2013 Additional efficacy and safety data will be featured across four posters \u2013<\/i><\/p>\n
BOSTON–(BUSINESS WIRE<\/a>)–Ironwood Pharmaceuticals, Inc.<\/a> (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present findings during the 2023 Digestive Disease Week\u00ae (DDW) from studies on the potential of linaclotide for children and adolescents ages 6-17 years-old with functional constipation. DDW is being held from May 6 through May 9 in Chicago, IL.<\/p>\n \nFunctional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass1<\/sup>.The condition affects an estimated 6 million children ages 6-17 years-old in the U.S.1<\/sup><\/p>\n \nAn oral presentation will discuss data from a Phase III clinical trial that evaluated the efficacy and safety of linaclotide 72 mcg in treating functional constipation in pediatric patients ages 6-17 years old. Ironwood had previously announced topline data from this trial in September 2022. Poster presentations will highlight data on the efficacy of linaclotide in addressing bothersome functional constipation symptoms in pediatric patients ages 6-17 years old, as well as aggregate data on the safety of linaclotide in this patient population.<\/p>\n \nLinaclotide is marketed as LINZESS\u00ae by Ironwood and AbbVie in the United States and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It is not approved for use in patients less than 18 years of age. Ironwood announced earlier this year that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application for LINZESS for the treatment of children and adolescents ages 6-17 years-old with functional constipation and assigned a Prescription Drug User Fee Act (PDUFA) date of June 14th<\/sup>, 2023. Additional pediatric clinical trials in IBS-C and functional constipation are ongoing. There are currently no FDA -approved prescription therapies for functional constipation.<\/p>\n \nAn overview of all five presentations is provided below.<\/p>\n Efficacy and Safety of Linaclotide in Pediatric Functional Constipation<\/b><\/p>\n Time to Response and Impact of Linaclotide on Bothersome Functional Constipation Symptoms in a Pediatric Population<\/b><\/p>\n Aggregate Safety Data in Patients with Functional Constipation Ages 6-17 Years-Old<\/b><\/p>\n About Linaclotide<\/b><\/p>\n \nLinaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS\u00ae for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA\u00ae for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood’s partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or chronic constipation. In China, (including Hong Kong and Macau) Ironwood\u2019s partner Astra Zeneca markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C. Ironwood is also partnered with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS\u00ae and CONSTELLA\u00ae are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.<\/p>\n LINZESS Important Safety Information<\/b><\/p>\n INDICATIONS AND USAGE<\/b><\/p>\n \nLINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).<\/p>\n IMPORTANT SAFETY INFORMATION<\/b><\/p>\n\n
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<\/i>(oral presentation, presentation number 145), by Carlo Di Lorenzo, M.D., Nationwide Children\u2019s Hospital, Columbus, OH, on Saturday, May 6, from 10:15 to 10:30 a.m. CST in room W195<\/p>\n<\/li>\n<\/ul>\n\n
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<\/i>(poster presentation number Mo2007), presented by Julie Khlevner, M.D., New York Presbyterian Morgan Stanley Children\u2019s Hospital, New York, NY, on Monday, May 8, from 12:30 to 1:30pm CST<\/p>\n<\/li>\n
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<\/i>(poster presentation number Mo2008), by Samuel Nurko, M.D., Boston Children\u2019s Hospital, Boston, MA, on Monday, May 8, from 12:30 to 1:30 p.m. CST<\/p>\n<\/li>\n<\/ul>\n\n
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<\/i>(poster presentation number Mo2016), by Miguel Saps, M.D., University of Miami, Miami, FL, on Monday, May 8, from 12:30 to 1:30 p.m. CST<\/p>\n<\/li>\n
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