FDA approves Synergy's constipation drug

FDA approved once-daily oral Trulance plecanatide from Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) to treat chronic idiopathic constipation (CIC) in adults. Spokesperson Gem Hopkins told BioCentury that Synergy plans to launch the drug this quarter, and would disclose the price at launch.

The agency said patients treated with Trulance may experience severe diarrhea, the drug's most common and serious side effect. FDA also stated Trulance should not be used in patients with known or suspected mechanical gastrointestinal obstructions. Trulance is a uroguanylin analog and guanylate cyclase C (GCC; GUCY2C) agonist...