BRIEF—New linaclotide Phase III data in children with functional constipation

USA-based gastroenterology specialist Ironwood Pharmaceuticals announced that new data from the Phase III study that evaluated linaclotide in children and adolescents aged 6-17 years with functional constipation were published in The Lancet Gastroenterology & Hepatology (article  here).

The data highlight additional efficacy endpoints from the company’s pivotal Phase III trial, which formed the basis of the June 2023 Food and Drug Administration (FDA) approval of linaclotide for the treatment of functional constipation in this 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 around 13% of all children worldwide. It is one of the most common complaints patients bring to their pediatricians and pediatric gastroenterologists.

Under trade name Linzess, linaclotide is the first and only FDA approved prescription therapy for children and adolescents aged 6-17 years with functional constipation.