Synergy has announced that they have submitted a supplemental New Drug Application (sNDA) for Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Plecanatide is similar to uroguanylin, a naturally occurring and endogenous human GI peptide, which stimulates fluid secretion and maintains stool consistency necessary for regular bowl function. It was approved in January to treat chronic idiopathic constipation (CIC).
The new application for an IBS-C indication is supported by data from two placebo-controlled Phase 3 studies that lasted 12 weeks and evaluated plecanatide in 2,100 patients with IBS-C. In both trials, 3mg and 6mg doses of plecanatide met the primary endpoint of statistical significance in the percentage of patients who were overall responders compared to placebo.
In Study 1, 21.5% of the 3mg group and 24.0% of the 6mg group were overall responders compared to 14.2% in the placebo group, (P=0.009 for 3mg) and (P<0.001 for 6mg). In Study 2, 30.2% of the 3mg group and 29.5% of the 6mg group were overall responders compared to 17.8% in the placebo group, (P<0.001 for 3mg) and (P<0.001 for 6mg).
The overall responder rate is the primary endpoint required by the Food and Drug Administration (FDA) for approvals in the IBS-C category. The definition of an overall responder is a patient who fulfills both ≥30% reduction in worst abdominal pain and an increase of ≥1 complete spontaneous bowel movement (CSBM) from baseline, in the same week for at least 50% of the 12 treatment weeks.
The most common adverse event in both studies was diarrhea (Study 1: 3.2% at 3mg and 3.7% at 6mg compared to 1.3% for placebo; Study 2: 5.4% at 3mg and 4.3% at 6mg compared to 0.6% for placebo).
For more information visit Synergypharma.com.