Linaclotide Phase III Study in 6-17 Year Olds with Functional Constipation Published in The Lancet Gastroenterology & Hepatology

New research findings have been published in The Lancet Gastroenterology & Hepatology, showcasing the efficacy of linaclotide in treating functional constipation in children and adolescents aged 6-17. Ironwood Pharmaceuticals, a company dedicated to gastrointestinal health, announced the results of their Phase III study which contributed to the FDA's approval of linaclotide for this specific age group in June 2023.

Functional constipation in children is characterized by hard, infrequent stools that are often difficult to pass, affecting an estimated 6 million children in the U.S. The study involved 328 participants who were randomly assigned to receive either linaclotide 72 mcg or a placebo. Over a 12-week period, linaclotide showed significant improvement in bowel movement frequency, the primary endpoint of the study. The treatment group experienced a more than two-fold increase in weekly bowel movements compared to the placebo group, with a p-value of less than 0.0001, indicating a highly statistically significant result.

Moreover, the stool consistency, measured by the Bristol Stool Form Scale, improved in the linaclotide group. This scale ranges from 1, indicating hard and difficult-to-pass stools, to 7, indicating liquid stools. The percentage of patients with at least one bowel movement within 24 or 48 hours of the first dose was also higher in the linaclotide group.

Linaclotide was found to be well-tolerated, with similar proportions of adverse events reported in both the treatment and placebo groups. The most common adverse event in the linaclotide group was diarrhea, which was mild in most cases.

The publication in The Lancet Gastroenterology & Hepatology detailed additional findings, such as a higher percentage of weekly bowel movement responders in the linaclotide group compared to placebo across several weeks of the study. Furthermore, fewer patients in the linaclotide group reported an increase in rescue medication use or the need for other laxatives, suppositories, or enemas.

Linaclotide, marketed as LINZESS®, is now available in the U.S. for pediatric patients aged 6-17 with functional constipation. Ironwood Pharmaceuticals is committed to sharing ongoing data with medical professionals and the scientific community to address unmet needs in pediatric gastrointestinal care.

LINZESS is also the leading prescribed brand in the U.S. for treating adult patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). The medication works by activating the GC-C receptor in the intestine, which is believed to increase intestinal fluid secretion and transit speed while decreasing the activity of pain-sensing nerves in the intestine.

Ironwood Pharmaceuticals, in collaboration with AbbVie, develops and markets LINZESS for adults with IBS-C or CIC in the U.S. The company is also involved in the development of other gastrointestinal treatments, such as apraglutide for short bowel syndrome with intestinal failure and other early-stage assets, with the aim of improving the standard of care for GI patients.