Plecanatide (Trulance), an uroguanylin analog, received FDA approval for treatment of chronic idiopathic constipation (CIC) in adults. "Taken orally once daily, [plecanatide] works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function," the FDA said. The FDA announcement said the safety and efficacy of plecanatide, which was developed by Synergy Pharmaceuticals of New York, were established in two 12-week, placebo-controlled trials including 1,775 adult participants. All patients had at least a 6-month history of constipation including less than three defecations weekly for 3 months prior to study onset. Patients were randomly assigned to placebo or active treatment. The patients in the plecanatide group "were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining." The most common side effect was diarrhea. The drug should not be used in children less than 6 due to the risk of dehydration and should be avoided in children ages 6 to 18.
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