FDA has announced it has approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation in adults, according to a news release.
Linzess is a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of the day. Linzess helps relieve constipation by helping bowel movements occur more often. In IBS-C, it may also help ease abdominal pain.
"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, in the release. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."
The most common side effect of Linzess reported during the clinical studies was diarrhea.
Linzess is co-marketed by Ironwood Pharmaceuticals, based in Cambridge, Mass., and Forest Pharmaceuticals, based in St. Louis, Mo.
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