Skip to main content

FDA Approves Linzess to Treat Constipation in Children, Teens

Medically reviewed by Drugs.com.

By Lori Solomon HealthDay Reporter

WEDNESDAY, June 14, 2023 -- The U.S. Food and Drug Administration approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years with functional constipation.

The approval was based on data from 328 participants who were randomly assigned (1:1) to receive Linzess or placebo. A statistically significant benefit and clinically meaningful improvement was seen for 12-week spontaneous bowel movement frequency rate with Linzess compared with placebo, with Linzess-treated patients showing a greater than twofold least squares mean change from baseline in spontaneous bowel movements per week (2.6 versus 1.3). Diarrhea was the most common adverse event reported (4 percent of Linzess-treated patients versus 2 percent of placebo-treated patients).

"Pediatric functional constipation is an all-too-common issue that physicians see every day, yet despite the tremendous distress it causes to our patients and their families, we haven't had an FDA-approved prescription treatment to offer until now," Jeffrey S. Hyams, M.D., from the Connecticut Children’s Medical Center and the University of Connecticut in Hartford, said in a statement. "The approval of Linzess for the treatment of functional constipation in pediatric patients ages 6 to 17 years old is a meaningful advancement for these young patients."

Expanded approval of Linzess was granted to Ironwood Pharmaceuticals.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted June 2023

Read this next

Mind, Body Symptoms Can Precede MS Diagnosis for Years

WEDNESDAY, Dec. 6, 2023 -- Patients in the earliest stages of multiple sclerosis might develop certain symptoms that offer an early clue to the degenerative nerve disease...

Constipation May Be a Marker for Dementia Risk

WEDNESDAY, July 19, 2023 -- Chronic constipation may not only be an indicator of gut health, but a potential warning sign of thinking declines, a preliminary study...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.