Upset Belly Pill Approved

Linzess approved to treat severe constipation, irritable bowel syndrome

(RxWiki News) Those uncomfortable and sometimes painful trips to the bathroom may be a little easier to deal with. The US Food and Drug Administration approved Linzess, which is a new drug used to treat bad cases of irritable bowel syndrome and chronic constipation in adults.

Linzess helps people diagnosed with a type of constipation that  does not respond to normal treatments.

This drug also treats irritable bowel syndrome with constipation (IBS-C). Patients usually have pain in the abdomen and have different stool sizes and textures.

"Talk to your doctor before IBS drugs."

Two studies, under the direction of Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research, involved 1,272 patients to test how safe and effective the medication is.

Linzess, a pill that contains the active ingredient linaclotide, helps patients with chronic idiopathic constipation, as well as irritable bowel syndrome with constipation (IBS-C). The drug is taken on an empty stomach 30 minutes or more before the first meal of the day. Each of the participants were randomly assigned to one of three groups to take a designated dosage of the pill for 12 weeks.

One group received 145 mcg of the Linzess, another received 290 mcg, and the third had a fake pill or placebo. Neither the researchers nor the participants knew who was receiving which medication or dosage.

Researchers found that those who took Linzess had more complete and regular bowel movements. The 290 mcg dose was not more effective than the lesser amount and thus was not approved for chronic constipation.

The most common side effect was diarrhea during the clinical studies. The medication helps bowel movements occur more frequently to help relieve constipation.

About 63 million people are affected by chronic constipation, according to the National Institutes of Health. Further, about 15.3 million people experience IBS.

Because the drug should not be used in patients 17 years old and younger, Linzess is approved with a Boxed Warning label to keep patients and health care professionals aware.

“No one medication works for all patients suffering from these gastrointestinal disorders,” Dr. Kusiask said.

“With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition.”

The medication is co-marketed by Ironwood Pharmaceuticals Inc. and Forest Pharmaceuticals Inc., based in Massachusetts and Missouri respectively. 

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Review Date: 
August 30, 2012