Synergy Pharmaceuticals confirmed that FDA has approved Trulance™ (plecanatide), a once-daily, oral drug for treating chronic idiopathic constipation (CIC) in adults. The guanylate cyclase-C (GC-C) agonist is designed to mimic the human gastrointestinal peptide uroguanylin. Launch of Trulance in the U.S. is expected during Q1 2017.
Synergy says about 33 million people in the U.S. and 14% of the global population suffer with CIC, which doesn't have an identifiable cause. “We are thrilled with the approval of Trulance because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition,” said Gary S. Jacob, Ph.D., chairman and CEO of Synergy Pharmaceuticals.
FDA approval of Trulance was based on data from two placebo-controlled Phase III studies, which enrolled more than 2600 patients. The trial data showed that Trulance-treated patients achieved a greater efficacy response rate and improvements in stool frequency and consistency. “Trulance presents an exciting new treatment option for patients with chronic constipation,” added William D. Chey, M.D., professor of medicine, director of the GI Physiology Laboratory, and co-director of the Michigan Bowel Control Program at the University of Michigan. “Its efficacy and safety profile, plus its negligible systemic absorption, are attractive attributes that make it a welcome addition to our treatment options.”
Synergy has also completed two Phase III studies evaluating Trulance for treating irritable bowel syndrome with constipation (IBS-C). Study data were reported last month. The firm says it expects to file an Trulance sNDA with FDA for the IBS-C indication during Q1 2017.
Synergy is separately developing a second uroguanylin analog, dolcanatide, for the treatment of ulcerative colitis. A positive proof of concept study was completed in January 2016. In February 2016, Synergy announced a research collaboration with BIND Therapeutics, focused on combining uroguanylin analogs with BIND’s targeted nanoparticle Accurins® platform, for the potential treatment of gastrointestinal tumors.