Synergy said that n August 5 the company completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding Synergy’s drug plecanatide for the treatment of chronic idiopathic constipation, or CIC. Agreement was reached with the FDA on design, duration, size and primary and secondary efficacy endpoints for pivotal phase 3 studies. A pivotal phase 3 program evaluating the safety and efficacy of plecanatide in CIC patients is expected to be initiated in the fourth quarter of 2013.
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