Synergy announced that the Food and Drug Administration (FDA) has approved Trulance (plecanatide) tablets for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Approval of the new indication was supported by data from the Phase 3 IBS-C program that included 2 randomized, 12-week, double-blind, placebo-controlled trials in adults with IBS-C. Over 2,100 patients received Trulance 3mg once daily, 6mg once daily, or placebo. In both trials, the primary endpoint was the percentage of patients who were overall responders during the 12-week treatment period. An overall responder was defined as a patient who fulfilled both ≥30% reduction in worst abdominal pain and an increase of ≥1 complete spontaneous bowel movement (CSBM) from baseline, in the same week, for ≥50% of the 12 treatment weeks.
Trulance achieved the primary endpoint in both trials vs. placebo with 30.2% vs. 17.8% (P<0.001) of patients being overall responders in Study 1 and 21.5% vs. 14.2% (P=0.009) of patients in Study 2, respectively. Patients treated with Trulance also had significantly reduced abdominal pain and improved stool frequency, stool consistency, and straining with bowel movements during the treatment period vs. placebo. Diarrhea was the most frequent adverse event (4.3% Trulance vs 1.0% placebo) reported, while severe diarrhea occurring in 1% of patients.
Trulance, a guanylate cyclase-C agonist, is already indicated to treat adults with chronic idiopathic constipation (CIC). Apart from a single amino acid substitution, Trulance is structurally identical to human uroguanylin and is thought to replicate the pH-sensitive activity of uroguanylin.
Trulance is available as 3mg tablets in 30-count bottle and a 30-count calendar blister pack.
For more information call (888) 869-8869 or visit Trulance.com.