FDA Approves Unique Treatment for Chronic Idiopathic Constipation

The approval is based on two Phase 3 trials including over 2,000 patients with constipation
The approval is based on two Phase 3 trials including over 2,000 patients with constipation

Trulance (plecanatide tablets; Synergy) has been approved by the Food and Drug Administration (FDA) for the treatment of chronic idiopathic constipation (CIC) in adult patients.

Plecanatide is structurally related to uroguanylin, a naturally occurring and endogenous gastrointestinal (GI) peptide. Trulance, taken orally once daily, works locally in the upper GI tract to stimulate secretion of intestinal fluid and support regular bowel function.

The approval is based on data from two Phase 3, 12-week, placebo-controlled trials which included more than 2600 patients. Patients were required to have been diagnosed with constipation at least six months prior to the study onset and to have <3 defecations/week in the previous three months, as well as other symptoms associated with constipation.  

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The primary endpoint of the study was efficacy responder rate; efficacy responders were defined as patients who had at least three complete spontaneous bowel movements (CSBMs) in a given week and an increase of at least one CSBM over baseline in the same week for at least nine weeks out of the 12-week period, including at least three of the last four weeks.  

Over 12 weeks, in both studies, compared to placebo, patients treated with Trulance achieved a significantly greater efficacy responder rate (Study 1: 21% vs. 10%; Study 2: 21% vs. 13%, p<0.005 for both studies). In addition, patients treated with Trulance also had improvements as compared to placebo in stool frequency (as measured by the number of spontaneous bowel movements per week), stool consistency (as measured by the Bristol Stool Form Scale) and straining with bowel movements.

Diarrhea was the most common adverse event reported, with 5% of Trulance patients experiencing it versus 1% of placebo-treated patients. 

Synergy has stated that Trulance will become available later this quarter.

“With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition,” said Julie Beitz, MD, director of the FDA's Center for Drug Evaluation and Research. 

For more information visit synergypharma.com.