FDA Approves Trulance for Chronic Idiopathic Constipation
Drug designed to stimulate secretion of intestinal fluid
FRIDAY, Jan. 20, 2017 (HealthDay News) -- Trulance (plecanatide) has been approved by the U.S. Food and Drug Administration to treat persistent idiopathic constipation in adults.
Once-daily Trulance is designed to stimulate the gastrointestinal tract to secrete fluid and "support regular bowel function," the FDA said in a news release.
The oral drug was evaluated in two 12-week clinical studies involving a total of 1,775 adults with chronic constipation. Compared to patients taking placebo, those taking Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements, as well as improvements in stool frequency and consistency and straining. Diarrhea was the most common side effect. If diarrhea becomes severe, users should stop taking Trulance and contact a doctor, the FDA advised.
"No one medication works for all patients suffering from chronic gastrointestinal disorders," Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in a statement. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."
Trulance is produced by New York City-based Synergy Pharmaceuticals.