Synergy: Plecanatide associated with low adverse events in long-term study
Synergy Pharmaceuticals presented new long-term safety data of plecanatide, its investigational, orally-administered compound currently being evaluated by the U.S. FDA for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation. These data, which were presented at the American College of Gastroenterology annual scientific meeting, showed that plecanatide was associated with low adverse events and low discontinuation rates in patients with CIC who received plecanatide once-daily for up to 72 weeks. In this long-term study, which evaluated 2,370 patients, the most common adverse events in both dose groups were diarrhea and urinary tract infection. The remainder of adverse events occurred in less than 2% of patients treated with plecanatide. Adverse events leading to discontinuation occurred in 5.3% of patients treated with plecanatide, with discontinuation due to diarrhea occurring in 3.1% of patients. In addition, this study asked patients about level of treatment satisfaction and desire to continue treatment. The median score for treatment satisfaction was 4.0 and for continuation of treatment was 4.0. The Prescription Drug User Fee Act target action date for plecanatide in CIC is January 29, 2017. In addition, 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. Pending approval in the CIC indication, Synergy 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 from submission.