Synergy Pharmaceuticals said Wednesday it will present new data on plecanatide, an investigational compound for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) at the American College of Gastroenterology annual meeting in Las Vegas in October.
Plecanatide is a once-daily, orally-administered compound currently being evaluated by the U.S. Food and Drug Administration. The Prescription Drug User Fee Act target action date for plecanatide is Jan. 29.
Synergy has already completed patient recruitment for the two double-blind placebo-controlled phase 3 clinical trials with plecanatide in IBS-C and remains on-track to report top-line data from both trials in the fourth quarter of this year.
The company plans to file a new drug application supplement with clinical data for plecanatide in IBS-C in the first quarter of 2017 and expects a 10-month review period.
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