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Shire's constipation drug wins US FDA approval

The U.S. Food and Drug Administration approved Shire plc's Motegrity to treat adult patients with chronic idiopathic constipation.

In chronic idiopathic constipation, the cause of the difficult, infrequent, or incomplete bowel movements, is unknown. The condition affects about 35 million adults in the U.S.

Motegrity, or prucalopride, is a selective serotonin type 4, or 5-HT4, receptor agonist that increases bowel motility or the movement in the intestines to push its content further.

The U.S. FDA's Gastrointestinal Drugs Advisory Committee previously backed Motegrity's approval in October, noting that the drug's benefit outweighs its risks. Other drugs which belong in the same class, such as Johnson & Johnson's Propulsid, also known as cisapride, and Novartis AG's Zelnorm, or tegaserod maleate, were recalled due to cardiovascular risks.

Motegrity is not approved for use in patients who have had a history of hypersensitivity to the drug or those with tears in the stomach or intestinal wall. The drug is also contraindicated for patients with bowel blockage or serious conditions of the intestinal wall, including Crohn's disease or ulcerative colitis.

The drug is being marketed as Resolor in the EU for treating chronic constipation in adults for whom laxatives fail to provide adequate relief.