– Pivotal Phase III data will be spotlighted via an oral presentation –
– Additional efficacy and safety data will be featured across four posters –
BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, announced today that the company will present findings during the 2023 Digestive Disease Week® (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.
Functional 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 ages 6-17 years-old in the U.S.1
An 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.
Linaclotide is marketed as LINZESS® 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, 2023. Additional pediatric clinical trials in IBS-C and functional constipation are ongoing. There are currently no FDA -approved prescription therapies for functional constipation.
An overview of all five presentations is provided below.
Efficacy and Safety of Linaclotide in Pediatric Functional Constipation
- Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients Aged 6-17 Years: A Phase III, Pivotal, Randomized, Placebo-Controlled Trial (oral presentation, presentation number 145), by Carlo Di Lorenzo, M.D., Nationwide Children’s Hospital, Columbus, OH, on Saturday, May 6, from 10:15 to 10:30 a.m. CST in room W195
Time to Response and Impact of Linaclotide on Bothersome Functional Constipation Symptoms in a Pediatric Population
- Efficacy of Linaclotide in Treating Symptoms of Incomplete Evacuation and Straining in Pediatric Patients with Functional Constipation (poster presentation number Mo2007), presented by Julie Khlevner, M.D., New York Presbyterian Morgan Stanley Children’s Hospital, New York, NY, on Monday, May 8, from 12:30 to 1:30pm CST
- Time to Response of Linaclotide in Treating Functional Constipation in Pediatric Patients Aged 6-17 Years: Data From a Phase 3, Randomized, Placebo-Controlled Trial (poster presentation number Mo2008), by Samuel Nurko, M.D., Boston Children’s Hospital, Boston, MA, on Monday, May 8, from 12:30 to 1:30 p.m. CST
Aggregate Safety Data in Patients with Functional Constipation Ages 6-17 Years-Old
- Long-Term Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients Aged 6-17 Years: Interim Analysis of an Open-Label, Phase 3, Extension Trial (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
- Safety of Linaclotide in Pediatric Patients with Functional Constipation: A Pooled Analysis of Placebo-Controlled, Randomized-Controlled Trials (poster presentation number Mo2015), presented by Jeffrey Samuel Hyams, M.D., Connecticut Children’s Medical Center, Hartford, CT, on Monday, May 8, from 12:30 to 1:30 p.m. CST
About Linaclotide
Linaclotide 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® for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® 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’s 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® and CONSTELLA® 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.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. |
Contraindications
- LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
- LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.
Diarrhea
- Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in