FDA approves Linzess for chronic constipation, irritable bowel syndrome

Constipation affects 63 million Americans, according to NIH

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating bowel diseases made by Ironwood Pharmaceuticals, the agency said Thursday.

The FDA announced the approval of Linzess (linaclotide) capsules for chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. Chronic constipation affects an estimated 63 million people in the United States, according to the National Institutes of Health; chronic idiopathic constipation occurs when patients' condition doesn't respond to standard treatment. An additional 15.3 million people have IBS.

"No one medication works for all patients suffering from these gastrointestinal disorders," Office of Drug Evaluation III deputy director Victoria Kusiak said. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."


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