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FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C

Published 08 June 2017

The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

The Prescription Drug User Fee Act (PDUFA) date is January 24, 2018.

TRULANCE is a once-daily tablet approved by the FDA for the treatment of adults with chronic idiopathic constipation (CIC) 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.

“This acceptance by the FDA is an important step forward for Synergy, building on the recent FDA approval and launch of TRULANCE for adults with CIC, and signaling the next step in our efforts to bring TRULANCE to the many millions of people living with IBS-C,” said Gary S. Jacob, Ph.D., Chairman and CEO, Synergy Pharmaceuticals Inc.

“This milestone is a testament to our entire team’s passion to the continued research and development of TRULANCE, which, if approved, represents an additional, much needed new treatment option for this complex disorder.”

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 (3 mg or 6 mg doses) 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 (Study 1: 30.2% in 3 mg and 29.5% in 6 mg dose groups compared to 17.8% in placebo; p<0.001 for 3 mg and p<0.001 for 6 mg; Study 2: 21.5% in 3 mg and 24.0% in 6 mg dose groups compared to 14.2% in placebo; p=0.009 for 3 mg and p<0.001 for 6 mg).

An Overall Responder, as defined by the U.S. Food and Drug Administration (FDA), is a patient who fulfills both ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movement (CSBM) over baseline, in the same week, for at least 50% of the 12 treatment weeks. This is the current primary endpoint required for FDA approval in IBS-C.

In both studies, the most common adverse event was diarrhea (Study 1 = 3.2% at 3 mg and 3.7% at 6 mg compared to 1.3% at placebo; Study 2 = 5.4% at 3 mg and 4.3% at 6 mg compared to 0.6% at placebo).

Source: Company Press Release