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SYNERGY PHARMACEUTICALS ANNOUNCES ACCEPTANCE OF NEW DRUG APPLICATION FOR PLECANATIDE, A NOVEL UROGUANYLIN ANALOG, IN CHRONIC IDIOPATHIC CONSTIPATION

APRIL 19, 2016
PDUFA target action date of January 29, 2017

NEW YORK-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today 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.
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Source: press release, 1/29/16. http://ir.synergypharma.com/press-releases/detail/1809/synergy-pharmaceu...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Plecanatide CICGastroenterologyChronic idiopathic constipation (CIC)Guanylate cyclase-C agonistGuanylate cyclase-C

Mechanism of action: Plecanatide is a guanylate cyclase-C (“GC-C”) agonist in development to treat patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) disorders. Plecanatide is a proprietary analog of uroguanylin, a hormone the body naturally produces to regulate critical GI functions. Orally administered plecanatide, like uroguanylin, binds to and activates the GC-C receptor expressed in the GI tract, resulting in fluid secretion and normalization of bowel movement.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-01-29

Results: Pending