Synergy Pharma Completes End-of-Phase 2 Meeting With FDA On Plecanatide

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) announced Tuesday that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration or FDA on its lead drug plecanatide for the treatment of irritable bowel syndrome with constipation or IBS-C.

The company said it reached an agreement 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 stated that its 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.