The recommended dosage in pediatric patients is 72 mcg orally once daily.
Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
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There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.
The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.
The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
Study details
To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.
They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:
- History of stool withholding or excessive voluntary stool retention.
- History of painful or hard bowel movements.
- 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 primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.
SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.
The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.
Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
The application for linaclotide in children received priority review.
A version of this article originally appeared on Medscape.com.