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Synergy Pharmaceuticals Inc announces successful end-of-phase 2 meeting with FDA for plecanatide in irritable bowel syndrome with constipation

Tuesday, 8 Jul 2014 06:00am EDT 

Synergy Pharmaceuticals Inc:Says pivotal phase 3 IBS-C Program to be initiated in the fourth quarter.Completes an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on lead drug plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C).Agreement was reached with the FDA for the plecanatide pivotal phase 3 IBS-C clinical development program that is scheduled to begin in the fourth quarter of this year.Synergy's pivotal phase 3 IBS-C clinical development program will consist of two registration trials, each including 1,050 patients who will receive either placebo, 3.0 mg or 6.0 mg plecanatide.IBS-C patients successfully completing either of the 12-week placebo-controlled registration trials will be offered enrollment into a long-term safety trial in order to complement and support the ongoing long-term safety database for the CIC indication. 

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29 Aug 2014