FDA approves Trulance for chronic idiopathic constipation treatment
Trulance has been approved for the treatment of chronic idiopathic constipation in adults.
The US Food and Drug Administration (FDA) has approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adults. Trulance is a once-daily oral medication that works in the upper gastrointestinal tract to stimulate secretion of intestinal fluid and support regular bowel function.
The FDA examined the safety and efficacy of Trulance from the data of two 12-week, placebo-controlled trials. The studies included 1,775 participants who were randomly assigned to receive once-daily Trulance or placebo. The participants were diagnosed with constipation at least 6 months prior to the study and had fewer than 3 defecations per week in the previous 3 months.
The results of the trials showed that participants taking Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those taking placebo. Participants receiving Trulance also had improvements in stool frequency and consistency and straining.
“No one medication works for all patients suffering from chronic gastrointestinal disorders,” stated Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. “With the availability of new therapies, patients and their [clinicians] can select the most appropriate treatment for their condition.”
The FDA notes that the safety and effectiveness of Trulance has not been established in patients younger than 18 years of age. Trulance should not be used in children younger than 6 years of age, due to risk of serious dehydration, and should be avoided in patients between 6 and 18 years of age. Patients with known or suspected mechanical gastrointestinal obstruction should not use Trulance.
The agency also states that the most common side effect of Trulance is diarrhea. Patients with severe diarrhea should stop taking Trulance and contact their healthcare provider.
- US Food and Drug Administration. FDA approves Trulance for Chronic Idiopathic Constipation [press release]. Published January 19, 2017. Accessed January 23, 2017.