FDA Approves Synergy’s Once-Daily Trulance for Chronic Constipation

The FDA approved Trulance (plecanatide), developed by Synergy Pharmaceuticals, for the treatment of adult chronic idiopathic constipation.

Oral, once-daily Trulance was evaluated in two 12-week, placebo-controlled trials enrolling 1,775 patients diagnosed with constipation at least six months prior to the study onset.

Patients receiving Trulance were more likely to experience improvement in the frequency of complete spontaneous bowel movements than those receiving placebo, and also had improvements in stool frequency and consistency and straining. The safety and effectiveness of Trulance have not been established in patients under 18, the FDA said.