FDA to Review Trulance for IBS With Constipation in Adults
Both plecanitide and its metabolite exhibit local activity on the intestinal epithelium, increasing intracellular and extracellular cGMP concentrations.
Synergy announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Trulance (plecanatide) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
The sNDA was based on 2 randomized, 12-week, double-blind, placebo-controlled Phase 3 studies (n > 2100) in which patients with IBS-C received either Trulance 3 mg or 6 mg once daily, or placebo. The primary endpoint of both studies was the percentage of patients who were overall responders, having demonstrated both ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the 12 treatment weeks.
Results from both studies showed Trulance was statistically superior to placebo in achieving the primary endpoint (Study 1: 30.2%, P <0.001 in 3 mg and 29.5% in 6 mg vs 17.8% in placebo; Study 2: 21.5% in 3 mg and 24.0% in 6 mg vs 14.2% in placebo).
Trulance is a guanylate cyclase-C (GC-C) agonist. Both plecanitide and its metabolite exhibit local activity on the intestinal epithelium, increasing intracellular and extracellular cyclic guanosine monophosphate (cGMP) concentrations. Increased cGMP stimulates production of intestinal fluid which aids in accelerating intestinal transit and establishing stool consistency.
Trulance is already approved for the treatment of chronic idiopathic constipation (CIC) in adults aged ≥18 years. It is available as 3 mg tablets in 30-count bottles.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 24, 2018.
For more information call (888) 869-8869 or visit Trulance.com.