The FDA approved plecanatide (Trulance) to treat adult patients with chronic idiopathic constipation, the agency announced in a Jan. 19 press release.
The oral medication is taken once per day and works in the upper GI tract to stimulate secretion of intestinal fluid, supporting regular bowel function. Safety and efficacy were demonstrated in two 12-week, placebo-controlled trials of 1,775 participants diagnosed with constipation, according to the FDA. Those who received the medication were more likely than those who received placebo to experience improvements in stool frequency, consistency, straining, and the frequency of complete spontaneous bowel movements, according to the release.
The most common side effect was diarrhea, and patients should stop taking the medication and contact their clinician if severe diarrhea occurs, the release stated. The medication should not be used in patients under age 18 or in those with known or suspected mechanical GI obstruction, according to the FDA.