FDA Approves Linzess (Linaclotide) for IBS and Constipation
Drug is available as once-daily capsules (Aug. 30)
On August 30, the FDA approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults.
According to the National Institutes of Health, an estimated 63 million people are affected by chronic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. In addition, an estimated 15.3 million people are affected by IBS. IBS-C is a subtype characterized mainly by abdominal pain and by hard or lumpy stools at least 25% of the time and loose or watery stools less than 25% of the time.
Linzess is a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. The drug helps relieve constipation by helping bowel movements to occur more often. In IBS-C, it may also help to ease abdominal pain.
The safety and effectiveness of Linzess for the management of IBS-C were established in two double-blind studies. A total of 1,604 patients were randomly assigned to receive Linzess (290 mcg) or placebo for at least 12 weeks. Linzess was more effective in reducing the amount of abdominal pain and in increasing the number of complete spontaneous bowel movements compared with placebo.
The safety and effectiveness of Linzess for the management of chronic idiopathic constipation also were established in two double-blind studies. A total of 1,272 patients were randomly assigned to receive Linzess (145 mcg or 290 mcg) or placebo for 12 weeks. Patients taking Linzess experienced more complete spontaneous bowel movements than did those taking placebo. The 290-mcg dose of Linzess is not approved for chronic constipation because studies indicated that it was no more effective than the 145-mcg dose.
Linzess was approved with a Boxed Warning to alert patients and healthcare professionals that the drug should not be used in patients 16 years of age and younger. Diarrhea was the most common side effect reported during clinical studies.
Linzess is marketed by Ironwood Pharmaceuticals Inc., based in Cambridge, Mass.
For more information, visit the FDA Web site.