Synergy Pharmaceuticals Inc. announced about their approval from U.S. Food and Drug Administration (FDA) for Trulance (plecanatide) 3mg tablet which is once-daily treatment for irritable bowel syndrome with constipation (IBS-C), especially for adults. Though Trulance already been approved for chronic idiopathic constipation (CIC) treatment, it’s become the second indication for Trulance.
In past 12 months, Synergy achieved pivotal milestone by approving their product for IBS-C treatment, product mentioned by Troy Hamilton, Pharm.D, CEO of Syngergy. He also mentioned that this approval also demonstrates their unwavering commitment to offer safe and effective treatment option for chronic GI disorders.
As of now, Trulance is the only prescription option for adults for CIC and now it’s also have once-daily treatment option, which can be taken with our without food, at any time of the day. Interestingly Trulance is packaged on a 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.
drugs.com
