FDA Approves Linaclotide for Pediatric Patients With Functional Constipation


The treatment represents the first approval for pediatric patients with functional constipation.

FDA Approves Linaclotide for Pediatric Patients With Functional Constipation

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved linaclotide (Linzess) capsules for the treatment of pediatric patients aged 6-17 years with functional constipation.1

The treatment, developed by Ironwood Pharmaceuticals, represents the first treatment to gain FDA approval to treat pediatric patients with this condition.

“Today, Ironwood has broken new ground again in the history of LINZESS, extending the clinical utility of our blockbuster treatment to 6-17-year-olds seeking relief for their debilitating GI symptoms of functional constipation," Tom McCourt, CEO, Ironwood, said in a statement. This approval is a momentous step forward in progressing our mission to advance the treatment of GI diseases and redefine the standard of care for GI patients and in ushering in a new era of growth for our company.”

The recommended dosage is 72 mcg orally once daily.

The approval is based on the results of a 12 week, double-blind, placebo-controlled, randomized, multicenter clinical trial of pediatric patients with functional constipation, as well as efficacy data from adequate and well-controlled trials of adults with chronic idiopathic constipation.

Patients included in the first study had less than 3 spontaneous bowel movements per week and 1 or more of the following criteria at least once per week for at least 2 months prior to being screened:

  • History of stool withholding or excessive voluntary stool retention
  • History of painful or hard bowel movements (BMs)
  • History of large diameter stools that may obstruct the toilet
  • Presence of a large fecal mass in the rectum
  • At least one episode of fecal incontinence per week

The results show patients treated with linaclotide had a greater improvement in the average spontaneous bowel movements per week compared to the placebo group. This improved during week 1 and was maintained throughout the duration of the study.

In the safety analysis, they found the most common adverse reaction was diarrhea. Patients are recommended to discontinue the treatment if severe diarrhea occurs.

There is also a boxed warning on linaclotide for patients less than 2 years of age.


Center for Drug Evaluation and Research. (n.d.). FDA approves first treatment for pediatric functional constipation. U.S. Food and Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-pediatric-functional-constipation?utm_medium=email&utm_source=govdelivery

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