insidermonkey.com 30 Dec, 2016
Synergy Pharmaceuticals Inc has provided an update on topline results from a Phase 3 study of its candidate plecanatide. The study evaluated the efficacy and safety of plecanatide as a treatment for irritable bowel syndrome with constipation (IBS-C) in adults. The positive outcome from the Phase 3 trial of plecanatide in IBS-C patients paves the way for the firm to expand the treatment label of the drug. Plecanatide is already under review by the FDA as a treatment for Chronic Idiopathic Constipation (CIC) and decision on the ongoing review is expected on 29th January, 2017. The firm plans to make a Supplement New Drug Application (sNDA) for plecanatide as a treatment of IBS-C in 1Q17.