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TRULANCE is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion which results in a stool consistency associated with more regular bowel function. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170119006330/en/ We are thrilled with the approval of TRULANCE because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition, said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. I am confident that we truly have the right team with the right strategic vision and the right launch plan to successfully bring TRULANCE into this large but underserved market. CIC is a complex, functional GI disorder defined by symptoms including fewer than three bowel movements a week and hard-to-pass or incomplete bowel movements, for which there is no identifiable cause. [1,2] CIC affects approximately 33 million Americans and an estimated 14 percent of the global population. [2] The efficacy and safety of TRULANCE was evaluated in the largest Phase 3 CIC clinical trials to date, which included more than 2,600 patients in two randomized, 12-week, double-blind, placebo-controlled studies of TRULANCE. 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 (study 1:21% vs. 10%)(study 2:21% vs.


For the original version including any supplementary images or video, visit http://www.marketwatch.com/story/synergy-pharmaceuticals-trulancetmplecanatide-receives-us-fda-approval-for-the-treatment-of-adults-with-chronic-idiopathic-constipation-2017-01-19-19159270



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