New Option for Chronic Idiopathic Constipation Approved by the FDA

The FDA has approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adults.

Trulance is taken orally once daily, and works in the upper GI tract to stimulate secretion of intestinal fluid and support bowel function.
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The safety and efficacy of Trulance was tested in two 12-week, placebo-controlled trials involving 1775 participants who were randomly assigned to either Trulance or placebo. Participants had been diagnosed with constipation at least 6 month prior to the study and all had less than 3 defecations per week in the previous 3 months.

Overall, those who received Trulance were more likely to experience improvement in the frequency of spontaneous bowel movements than those taking placebo.

Trulance should not be used in children less than 6 years of age, and avoided in patients aged 6 to 18 years.

The most common side effect was diarrhea.

—Michael Potts

Reference:

FDA. FDA approves Trulance for chronic idiopathic constipation [press release]. January 19, 2017. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537725.htm.