Synergy Pharmaceuticals announces acceptance of sNDA for TRULANCE
Synergy Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application for TRULANCE for the treatment of adults with irritable bowel syndrome with constipation. The Prescription Drug User Fee Act date is January 24, 2018. TRULANCE is a once-daily tablet approved by the FDA for the treatment of adults with chronic idiopathic constipation and is currently being evaluated for the treatment of adults with IBS-C. The recommended dosage of TRULANCE for CIC is 3 mg taken orally, once daily, with or without food at any time of the day. The application is based on data from two randomized, 12-week, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of TRULANCE for the treatment of adults with IBS-C. Across the two trials, more than 2,100 patients received a once-daily tablet of TRULANCE or placebo. In these studies, TRULANCE 3 mg and 6 mg doses met the primary endpoint showing statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period. In both studies, the most common adverse event was diarrhea.