FDA Approves Linzess to Treat Constipation in Children, Teens

WEDNESDAY, June 14, 2023 (HealthDay News) -- 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.
Related Posts
Johnson & Johnson Agrees to $8.9 Billion Settlement in Talcum Powder Lawsuit
WEDNESDAY, April 5, 2023 (HealthDay News) -- Tens of thousands of people suing...
Reduced eGFR Linked to Increased Mortality in A-Fib
THURSDAY, Dec. 22, 2022 (HealthDay News) -- Moderately-to-severely reduced...
Even a Little Coffee in Pregnancy Might Stunt a Child’s Growth
TUESDAY, Nov. 1, 2022 (HealthDay News) -- Most pregnant women are told it's safe...
AHA News: She Tried to Forget Her Stroke. Now, She’s Putting It Into Words.
FRIDAY, Sept. 9, 2022 (American Heart Association News) -- Beth Bonness talked...