Synergy Pharmaceuticals sees presenting more Phase 3 IBS-C data later in 2017
"In December 2016, we announced positive top-line results in the two Phase 3 clinical trials of TRULANCE for the treatment of adults with IBS-C," the company said. "In both trials, TRULANCE met the study's primary endpoint showing statistical significance in the percentage of patients who were overall responders compared to placebo during the 12-week treatment period. An Overall Responder, as defined by the FDA, is a patient who fulfills both greater than or equal to 30% reduction in worst abdominal pain and an increase of greater than or equal to 1 complete spontaneous bowel movement from baseline, in the same week, for at least 50% of the 12 treatment weeks. This is the current primary endpoint required for FDA approval in IBS-C. In both studies, the most common adverse event was diarrhea. We plan to file a new drug application supplement with clinical data in the first quarter of 2017 and expect a 10-month review period from submission. We plan to present additional Phase 3 data from the two IBS-C trials at an appropriate scientific meeting later this year."