Pivotal phase 3 data results for Trulance (plecanatide) in the treatment of chronic idiopathic constipation (CIC) published in American Journal of Gastroenterology.
Synergy Pharmaceuticals Inc. announced that the American Journal of Gastroenterology has published detailed results from a pivotal phase 3 trial that demonstrated the efficacy and safety of Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC).
On Jan. 19, Trulance was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with CIC. Trulance is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion within the changing pH environment of the intestine.
“We are very pleased that our pivotal Phase 3 results are appearing in the American Journal of Gastroenterology, as these robust data demonstrate the efficacy and safety profile of Trulance, and add momentum to the FDA’s recent approval of Trulance,” said Gary S. Jacob, Ph.D., chairman and CEO of Synergy Pharmaceuticals Inc. “The publication of these data are a testament to the dedication of our researchers and the hard work of our entire Synergy team, all of whom are excited to be bringing Trulance to healthcare providers and their patients with the upcoming launch of this drug.”
Trulance will be available in the U.S. this quarter.
“There are millions of CIC patients in the U.S., many of whom suffer with symptoms that remain untreated or fail to respond to current treatments,” said Satish S.C. Rao, M.D., Ph.D., professor of medicine and director, neurogastroenterology/motility, Digestive Health Center at Augusta University. “Trulance has demonstrated efficacy with a low rate of adverse events, such as diarrhea, providing healthcare providers and their patients with an additional, much needed, new treatment option.”
In this study, diarrhea was the most common adverse event (Trulance 3 mg, 5.9%; placebo, 1.3%).
The approved dosing regimen for Trulance is 3 mg taken orally, once daily, with or without food at any time of the day. Trulance can be swallowed whole or crushed in applesauce for those who are unable to swallow medication.
Synergy has also completed two Phase 3 clinical trials for Trulance in irritable bowel syndrome with constipation (IBS-C), with positive top-line results of these trials announced in December 2016. Synergy plans to file a New Drug Application Supplement with Clinical Data (sNDA) this quarter with an expected 10-month review period from submission.
(Source: Business Wire)
Filed Under: Drug Discovery