FDA Alert

First Treatment for Pediatric Functional Constipation Approved by FDA

Jessica Ganga

The FDA has approved linaclotide to treat functional constipation in pediatric patients aged 6 to 17 years of age—the first treatment of its kind for this population.

A common condition, functional constipation is experienced by children and adolescents. Patients experience infrequent bowel movements with hard stools that can be difficult and painful to pass. Currently, there is no known underlying organic cause, and there are typically multiple contributing factors, according to the press release.

The approval follows a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial. Additionally, the trial was supported by efficacy data from “adequate and well-controlled trials in adults with chronic idiopathic constipation (constipation that persists and isn’t connected to an underlying illness),” according to the press release.

Rome II diagnostic criteria for functional constipation were modified to require that patients have less than three spontaneous bowel movements (SBMs) per week to participate in the clinical trial. The SBMs had to have occurred in the absence of laxative, enema, or suppository use on the calendar day of or before the bowel movement. Further, the participants had to meet one or more of the following criteria once per week for at least two months before the screening visit:

  • A history of withholding or excessively retaining stool
  • A history of painful or hard bowel movements
  • History of stools with a large diameter that may obstruct the toilet
  • Presence of a large fecal mass in the rectum
  • Fecal incontinence occurring at least once per week.

The primary endpoint was a 12-week change from baseline in SBM frequency rate. The results showed that patients who received treatment experienced an improvement in the average SBMs per week when compared to those who received placebo.

The most common adverse event reported was diarrhea. According to the press release, if severe diarrhea occurs, patients should stop treatment and be rehydrated. Additionally, the medication is not for patients aged 2 years and younger.

 

Reference:

FDA approves first treatment for pediatric functional constipation. News release. US Food and Drug Administration; June 12, 2023. Accessed June 14, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-pediatric-functional-constipation