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FDA Approves Trulance for Chronic Idiopathic Constipation
The FDA has approved plecanatide (Trulance, Synergy Pharmaceuticals), a uroguanylin analogue, for the treatment of adults with chronic idiopathic constipation (CIC).
According to the National Institutes of Health, an estimated 42 million people are affected by constipation. CIC is a diagnosis given to those who experience persistent constipation and for which there is no structural or biochemical explanation.
Plecanatide, taken orally once daily, works locally in the upper gastrointestinal (GI) tract to stimulate the secretion of intestinal fluid and support regular bowel function.
The safety and efficacy of plecanatide were assessed in two 12-week, placebo-controlled trials involving a total of 1,775 adults. The subjects were randomly assigned to receive plecanatide or placebo once daily. The subjects were required to have been diagnosed with constipation at least six months before the start of the study and to have had fewer than three defecations per week during the previous three months, as well as other symptoms associated with constipation.
The studies found that subjects receiving plecanatide were more likely to experience an improvement in the frequency of complete spontaneous bowel movements compared with those receiving placebo, and also showed improvements in stool frequency and consistency and in straining.
Plecanatide should not be used in children less than 6 years of age because of the risk of serious dehydration. Plecanatide should be avoided in patients 6 to 18 years of age. The safety and efficacy of plecanatide have not been established in patients younger than 18 years of age. Plecanatide should not be used in patients with known or suspected mechanical GI obstruction.
In clinical studies, the most common and serious adverse effect of plecanatide was diarrhea. Patients may experience severe diarrhea. If severe diarrhea occurs, patients should stop taking plecanatide and contact their health care providers.
Source: FDA; January 19, 2017.