FDA Approves Linzess (linaclotide) for IBS-C, CIC, and Pediatric Functional Constipation

Linzess (linaclotide) is a guanylate cyclase-C agonist. It binds to and activates guanylate cyclase-C on the luminal surface of intestinal epithelial cells, leading to increased intracellular cyclic guanosine monophosphate (cGMP) levels. This stimulates fluid secretion and accelerates intestinal transit.

Linzess is indicated for: - Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. - Chronic idiopathic constipation (CIC) in adults. - Functional constipation (FC) in pediatric patients 6 years of age and older.

- IBS-C adults: 290 mcg orally once daily. - IBS-C pediatric patients 7 years and older: 145 mcg orally once daily. - CIC adults: 145 mcg orally once daily; 72 mcg once daily may be used based on individual presentation or tolerability. - FC pediatric patients 6 years and older: 72 mcg orally once daily. Take on empty stomach at least 30 minutes before a meal at approximately the same time each day. Swallow capsule whole; do not crush or chew. For patients unable to swallow, capsule may be opened and contents sprinkled on applesauce or mixed with water and administered immediately. For nasogastric or gastrostomy tube administration, mix beads with water and administer via tube.

Efficacy for IBS-C in adults was established in two double-blind, placebo-controlled trials (Trials 1 and 2). A total of 800 patients in Trial 1 and 804 patients in Trial 2 (mean age 44 years, 90% female, 77% white) received Linzess 290 mcg or placebo once daily. Patients met Rome II criteria for IBS and had mean abdominal pain score ≥3 (0-10 scale) and <3 complete spontaneous bowel movements (CSBMs) per week during baseline. Trial data for CIC and pediatric populations are not available in the label.

Not reported in label.

Linzess provides a treatment option for patients with IBS-C, CIC, and pediatric functional constipation. It is a guanylate cyclase-C agonist that addresses constipation and abdominal pain. Dosing varies by indication and age. The drug should be taken on an empty stomach.