FDA Approves Oral Treatment for Chronic Idiopathic Constipation

The FDA announced the approval of Trulance (plecanatide), Synergy’s once-daily oral treatment for chronic idiopathic constipation (CIC) in adult patients.

Those with CIC experience persistent constipation without structural or biochemical explanation. Trulance works in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

Trulance’s approval is based on two 12-week, placebo-controlled trials that tested the safety and efficacy of the drug. The trials included 1775 adult participants randomly assigned to receive either a placebo or Trulance, once daily. Participants receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and they also exhibited improvements in stool frequency, consistency, and straining.

The most serious adverse effect associated with Trulance was diarrhea.

Reference

FDA approves Trulance for Chronic Idiopathic Constipation [news release]. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm537725.htm. Accessed Jan. 19, 2017.