September 19, 2012

FDA Approves Linzess for Both Idiopathic,
IBS-Associated Constipation

Washington, D.C.—A new option is now available for adult patients with constipation, with or without coexisting irritable bowel syndrome (IBS).

The FDA recently approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in patients 18 or older.

Linaclotide, the drug’s active ingredient, is a first-in-class guanylate cyclase-C (GC-C) agonist and acts locally in the intestine with minimal systemic exposure, according to Forest Pharmaceuticals Inc., based in St. Louis, MO, which comarkets Linzess with Cambridge, MA,-based Ironwood Pharmaceuticals Inc.

Intestinal pain reduction is thought to result from an increase in cyclic guanosine monophosphate (cGMP), which has been shown to decrease the activity of pain-sensing nerves, according to a Forest press release.

Chronic constipation affects 63 million Americans, and another 15.3 million are affected by IBS, according to public health statistics. IBS-C is a subtype defined 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, a capsule taken once daily on an empty stomach at least 30 minutes before the first meal of the day, helps relieve constipation by helping bowel movements occur more often. It also has been shown to reduce abdominal pain in IBS-C.

“No one medication works for all patients suffering from these gastrointestinal disorders,” said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”

Two double-blind studies were used to establish the safety and effectiveness of Linzess for the management of IBS-C. A total of 1,604 patients were randomly assigned to take 290 micrograms of Linzess or a placebo for at least 12 weeks, with the Linzess group having less abdominal pain and more spontaneous bowel movements than placebo.

In two double-blind studies on the safety and effectiveness of Linzess for the management of chronic idiopathic constipation, a total of 1,272 patients were randomly assigned to take Linzess at doses of 145 mcg or 290 mcg or a placebo for 12 weeks. Those taking Linzess experienced more complete spontaneous bowel movements than those taking the placebo.

The 290-mcg dose is not approved for chronic constipation because studies indicated it was no more effective than the 145-mcg dose.

Linzess is approved with a Boxed Warning to alert patients and health care professionals that the drug should not be used in patients 17 years of age and younger. The most common side effect reported during the clinical studies was diarrhea.

U.S. Pharmacist Social Connect