FDA accepts filing of plecanatide as a treatment for chronic idiopathic constipation and fixes PDUFA date- Synergy Pharma

Synergy Pharmaceuticals has announced the 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 29 January 2017.

The NDA for plecanatide is supported by two double-blind placebo-controlled phase III 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 programme.