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FDA accepts NDA for plecanatide for chronic idiopathic constipation
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The FDA has accepted the New Drug Application for plecanatide for the treatment of chronic idiopathic constipation, having determined it is “sufficiently complete to permit a substantive review,” the manufacturer announced.
The FDA Prescription Drug User Fee Act target action date is January 29, 2017, according to the press release.
Plecanatide (Synergy Pharmaceuticals) is a uroguanylin analog being developed for use as a once-daily tablet for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). It is “designed to replicate the function of uroguanylin ... by working locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function,” according to the press release.
Synergy filed its first NDA for plecanatide in CIC following positive phase 3 data in two double blind placebo-controlled clinical trials involving more than 2,700 patients. Data from an open-label long-term safety study also support the NDA, according to the press release.
“This is a transformative milestone for our company and reflects our relentless commitment to bringing meaningful treatment options to patients suffering from GI diseases,” Gary S. Jacob, chairman and CEO of Synergy Pharmaceuticals, said in the press release. “If approved, we believe plecanatide will become an important new treatment option that will benefit patients with CIC.”
Two phase 3 trials for IBS-C are currently ongoing, the results of which are expected by the third quarter of the year, and the company intends to file its second NDA in IBS-C by the end of the year.
Disclosure: Jacob is employed by Synergy.