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Report on:((NASDAQ: SGYP)
Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) announced the U.S. Food and Drug Administration (FDA) has determined that the company’s New Drug Application (NDA) for plecanatide, its first uroguanylin analog, for the treatment of chronic idiopathic constipation (CIC) is sufficiently complete to permit a substantive review. The FDA Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017.
“This is a transformative milestone for our company and reflects our relentless commitment to bringing meaningful treatment options to patients suffering from GI diseases,” said Gary S. Jacob, Chairman and Chief Executive Officer of Synergy Pharmaceuticals. “If approved, we believe plecanatide will become an important new treatment option that will benefit patients with CIC. I want to thank the Synergy employees and outside consultants working on the CIC NDA for their hard work and dedication which contributed to this important milestone.”
The NDA for plecanatide is supported by two double-blind placebo-controlled phase 3 trials and one open-label long term safety study. A total of more than 2,700 patients with CIC received a once-daily dose of either plecanatide or placebo across the two placebo-controlled trials. Additionally, over 3,500 patients were exposed to plecanatide in the CIC clinical development program.
Plecanatide is our first uroguanylin analog currently being evaluated for use as a once-daily tablet for the treatment of two functional GI disorders, CIC and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally similar to uroguanylin with the exception of a single amino acid change. Plecanatide is designed to replicate the function of uroguanylin, a naturally occurring GI peptide, by working locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function. In 2015, we announced positive phase 3 data with plecanatide in two pivotal CIC clinical trials and on January 29, 2016 the company filed its first NDA for plecanatide in CIC. We presently have two ongoing phase 3 clinical trials with plecanatide in IBS-C and intend to file our second NDA in IBS-C by the end of this year. We expect top-line data results from both pivotal IBS-C trials in the third quarter of this year.
Source: Street Insider
Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.
Broad Street Alerts was previously compensated eighteen thousand five hundred dollars by star media llc for the mention of FNJN however, that contract has expired.