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New IBS Drug Linzess Approved

Linzess Relieves Constipation, Pain of Irritable Bowel Syndrome

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

Aug. 30, 2012 -- The FDA today approved Linzess, a new kind of drug that relieves constipation and pain for some adults with irritable bowel syndrome (IBS).

In drug trials, people with IBS with constipation (a subtype of IBS called IBS-C) had more frequent and better bowel movements and less abdominal pain after taking daily doses of Linzess. The drug often began working within the first few days of treatment.

Studies of people with chronic constipation (long-term constipation not caused by other conditions) showed that one in five patients returned to normal bowel movements after taking Linzess. And on average, chronic constipation patients taking Linzess had more frequent bowel movements, less straining, and less bloating and discomfort.

Not all IBS-C patients in the studies got total relief, say Noel Lee, MD, and Arnold Wald, MD, of the University of Wisconsin, in a June 2012 review of Linzess studies.

Lee and Wald find that Linzess can improve many of the symptoms of irritable bowel syndrome with relatively few side effects. "Nevertheless, it has proven effective in only a minority of patients," they note.

Even so, Lee and Wald conclude that Linzess "is an attractive drug because of its ability to alleviate symptoms of irritable bowel syndrome with a single daily dose."

Linzess' main side effect is diarrhea, but very few people taking Linzess have had severe diarrhea.

Linzess is intended only for adults and is not approved for anyone aged 17 and younger. Packages will carry a prominent warning about this.

Ironwood Pharmaceuticals says Linzess should be available in the fourth quarter of 2012.

SOURCES: News release, FDA. Lee, N. and Wald, A. Core Evidence, June 2012. Lembo, A.J. New England Journal of Medicine, Aug. 11, 2011. News release, Ironwood Pharmaceuticals and Forest Laboratories.

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