Synergy Submits SNDA For TRULANCE For Irritable Bowel Syndrome With Constipation

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) announced Monday that the company has submitted a supplemental New Drug Application or sNDA for TRULANCE (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation or IBS-C.

The company said the application is based on data from two randomized, 12-week, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of TRULANCE for the treatment of adults with IBS-C. Across the two trials, more than 2,100 patients received a once-daily tablet of TRULANCE (3 mg or 6 mg doses) or placebo.

Synergy announced positive results from the two Phase 3 trials of TRULANCE in adults with IBS-C in December 2016. In both trials, TRULANCE 3 mg and 6 mg doses met the primary endpoint showing statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period.

The company plans to present additional Phase 3 data from the two IBS-C trials at upcoming scientific meetings later this year.

On January 19, 2017, TRULANCE was approved in the United States for the treatment of adults with chronic idiopathic constipation or CIC and is now available in U.S. pharmacies. The recommended dosage of TRULANCE is 3 mg taken orally, once daily, with or without food at any time of the day.

Gary Jacob, Chairman and CEO, Synergy, said, "Following the successful launch of TRULANCE in CIC, the submission of this supplemental application marks another important milestone for Synergy in our ongoing quest to bring new treatments that address significant unmet medical needs to patients living with GI disorders... If approved, we believe TRULANCE will provide an additional, much-needed, new treatment option for people with IBS-C."