FDA Approves Linzess to Treat Children with Constipation

The FDA has approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years-old with functional constipation, which affects an estimated 6 million U.S. children in this age group.

Developed by Ironwood Pharmaceuticals and AbbVie, Linzees Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways. It binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.

The children’s dose is 72 mcg, and Ironwood indicated that this dose is now available with access on most formularies. For adults, the recommended dose is 290 mcg for irritable bowel syndrome patients and 145 mcg for chronic idiopathic constipation patients, with an average retail cost of about $594 for 30 tablets, according to GoodRx. Eligible patients can get a 90-day prescription for $30 through a Linzess savings card.

“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., head, Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children’s Medical Center, Professor of Pediatrics, University of Connecticut School of Medicine, said in a press release.

The FDA approval was based on the results of a phase 3 study evaluating 328 patients 6 to 17 years of age who received Linzess 72 mcg. Linzess showed a statistically significant improvement compared with placebo in 12-week spontaneous bowel movement (SBM) frequency rate (SBMs/week), the primary endpoint. The most common adverse event was diarrhea, which occurred in 4% of Linzess-treated patients.