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# FDA Approves a Synergy Pharma NDA for Trulance
- URL: https://www.fdaweb.com/fda-approves-a-synergy-pharma-nda-for-trulance/
- Published: 2017-01-20T12:00:00.000Z
- Updated: 2026-09-14T22:02:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137786

FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) for treating adults with chronic idiopathic constipation (CIC). The company says Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function.

  
Approval was based on data from 2 Phase 3 trial involving more than 2,600 patients. “Over 12 weeks, patients treated with Trulance achieved a significantly greater efficacy responder rate — the primary endpoint defined by the FDA for regulatory approval in CIC — in both studies compared to placebo...,” the company says. “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.”