Synergy Pharmaceuticals reports presentation of Phase 3 Trulance data
Synergy Pharmaceuticals announced that the company will present new data from an analysis of patients with moderate to very severe bloating at baseline who participated in two Phase 3 studies evaluating TRULANCE for the treatment of adults with chronic idiopathic constipation. These data will be presented at Digestive Disease Week, May 6-9. Over 12 weeks, patients with CIC and moderate, severe or very severe bloating symptoms at baseline and were treated with TRULANCE 3 mg or 6 mg doses achieved a significantly greater efficacy responder rate, the primary endpoint defined by the FDA for regulatory approval in CIC, in this analysis compared to placebo -- 18.8% for 3 mg and 16.3% for 6 mg compared to 9.5% for placebo. Efficacy responders were defined as patients who had at least three complete spontaneous bowel movements in a given week and an increase of at least one CSBM over baseline in the same week for at least nine weeks out of the 12-week treatment period, including at least three of the last four weeks. The symptom of bloating among these patients also showed statistically significant improvements for TRULANCE 3 mg and 6 mg compared to placebo. Improvements in abdominal bloating scores were statistically significant after one week and continued throughout the 12-week treatment period. Discontinuation rates were low across both groups -- 3.6% at 3 mg and 4.5% at 6 mg compared to 2.4% for placebo -- and discontinuations due to diarrhea were infrequent -- 1.0% at 3 mg and 1.6% at 6 mg compared to 0.2% for placebo.