NEW YORK–(BUSINESS WIRE)– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the U.S. Food and Drug Administration (FDA) has approved TRULANCE®(plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This is the second indication for TRULANCE, which is already approved for the treatment of adults with chronic idiopathic constipation (CIC).
“The IBS-C approval is a pivotal milestone for Synergy, representing the second approved indication for TRULANCE in the past 12 months,” said Troy Hamilton, Pharm.D., CEO of Synergy Pharmaceuticals Inc. “This approval demonstrates our unwavering commitment to provide a safe and effective treatment option for those patients living with these chronic GI disorders.”
TRULANCE is the only prescription medication for adults with CIC and now IBS-C that can be taken once-daily, with or without food, at any time of the day. TRULANCE is packaged in a unique, 30-day calendar blister pack.
“Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options,” said 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. “With this second indication for TRULANCE, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C.”
“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 diarrhea rate of less than 0.5% and no reports of severe diarrhea requiring hospitalization 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.”
With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to human uroguanylin and is the only treatment thought to replicate the pH-sensitive activity of uroguanylin.
TRULANCE® (plecanatide) is a once-daily tablet approved for adults with CIC or IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate – dolcanatide.
January 25, 2018