NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). Additionally, the company is providing an update on the ongoing irritable bowel syndrome with constipation (IBS-C) program.
We are pleased with the progress and ongoing dialogue with the FDA,” said Gary S. Jacob, Chairman and CEO of Synergy Pharmaceuticals, “We remain optimistic about the potential approval of plecanatide in CIC by the PDUFA date of January 29, 2017. I am also very pleased with the progress our commercial, medical affairs and supply chain teams have made in recent months as we anticipate bringing this important new treatment option to CIC patients and their caregivers early next year.”
Furthermore, the company has decided to continue patient enrollment for its two ongoing phase 3 clinical trials with plecanatide in IBS-C. The decision to continue enrollment comes after trial monitoring demonstrated a slower enrollment pace combined with an increase in the number of patients not meeting randomization criteria after the screening period prior to starting treatment.
“Our first priority is to ensure high quality trials that reflect our rigorous standards and expectations," said Dr. Jacob, "To that end, we are updating our timing for top-line data in both trials to the fourth quarter of this year and intend to file the plecanatide NDA in IBS-C in the first quarter of 2017. We remain confident that plecanatide will continue to deliver outstanding clinical results consistent with previous trials, ultimately providing an important treatment option for patients suffering from IBS-C.”
Read more: http://www.businesswire.com/news/home/20160715005112/en/Synergy-Pharmaceuticals-Update-Ongoing-FDA-Review-Plecanatide