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Synergy submits sNDA for CIC drug Trulance to treat IBS-C
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Synergy Pharmaceuticals announced it has submitted a supplemental New Drug Application to the FDA for Trulance for the treatment of adults with constipation-predominant irritable bowel syndrome.
Trulance (plecanatide, Synergy) is a guanylate cyclase-C (GC-C) agonist that was approved in January for the treatment of adults with chronic idiopathic constipation, and is now available in the U.S. at a recommended oral dosage of 3 mg once daily, according to a press release.
“If approved, we believe Trulance will provide an additional, much-needed, new treatment option for people with IBS-C,” Gary S. Jacob, PhD, chairman and CEO of Synergy, said in the press release.
Data from two double blind randomized controlled trials, which Synergy announced in December, support the application. Investigators randomly assigned over 2,100 patients with IBS-C to receive 3 mg or 6 mg Trulance once daily or placebo for 12 weeks. Both trials met the primary endpoint with a significantly greater proportion of overall responders — defined by the FDA as “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” — in the treatment vs. placebo groups.
In the first study, 21.5% who received 3 mg plecanatide and 24% who received 6 mg plecanatide were overall responders compared with 14.2% of the placebo group (P = .009 and P < .001, respectively). In the second study, 30.2% who received 3 mg plecanatide and 29.5% who received 6 mg plecanatide were overall responders compared with 17.8% of the placebo group (P < .001 for both.)
Diarrhea was the most common adverse event, occurring in 3.2% of the 3-mg group and 3.7% of the 6-mg group vs. 1.3% of the placebo group in the first study, and in 5.4% and 4.3% vs. 0.6% in the second study.
The company said in expects to share additional phase 3 trial data from these trials at scientific meetings this year.
Disclosures: Jacob is employed by Synergy.