25 January 2017 - Synergy Pharmaceuticals announced today that the U.S. FDA has approved Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation in adults. 

This is the second indication for Trulance, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC).

“The Trulance label reflects the strong and remarkably consistent efficacy and safety profile Trulance has demonstrated in treating over 4,700 patients across both CIC and IBS-C clinical trials,” said Patrick H. Griffin, MD, Chief Medical Officer of Synergy. “To-date, real world patient experience has supported the clinical trial data, highlighted by a post-marketing diarrhoea rate of less than 0.5% and no reports of severe diarrhoea requiring hospitalisation since the launch of the Trulance CIC indication. The IBS-C approval today builds on the already strong CIC label and further establishes Trulance as the first and only uroguanylin analog.”

Read Synergy Pharmaceuticals press release