Synergy Pharmaceuticals Offers Update On Ongoing Irritable Bowel Syndrome With Constipation Program

Synergy Pharmaceuticals Inc SGYP revealed that it reached the FDA mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). Moreover, the company said that that was also offering update on the ongoing irritable bowel syndrome with constipation (IBS-C) program.

Additionally, the company said it decided to continue patient enrollment for its two ongoing phase 3 clinical studies with plecanatide in IBS-C. According to the company, the decision to continue enrollment came after trial monitoring illustrated a slower enrollment pace integrated with an increase in the number of patients not meeting randomization criteria following the screening period prior to starting treatment.

Synergy Pharmaceuticals chairman and CEO, Gary Jacob, said, "We are pleased with the progress and ongoing dialogue with the FDA. 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."

He added that the company's first priority was to ensure high quality trials reflecting its rigorous standards and expectations. The company is also updating its timing for top-line data in both studies to the fourth quarter of the current year and plan to file the plecanatide NDA in IBS-C in the first quarter of the next year.

Jacob concluded, "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."

The stock dipped 7 percent on Friday.