FDA accepts application to add IBS-C indication for Trulance

The FDA has accepted Synergy Pharmaceuticals’ supplemental new drug application to add constipation-predominant irritable bowel syndrome as an indication for Trulance, the company announced.

Trulance (plecanatide, Synergy Pharmaceuticals) is a guanylate cyclase-C (GC-C) agonist, which the FDA approved in January as a once-daily oral tablet for the treatment of adults with chronic idiopathic constipation.

The company’s sNDA follows the results of two phase 3 randomized controlled trials recently presented at DDW, both of which met their primary endpoints.

“Plecanatide was efficacious, safe and had a low rate of diarrhea in adult patients with IBS-C,” Ronald Fogel, MD, of the Clinical Research Institute of Michigan, said during his presentation.

In the two identically designed, double blind trials, researchers randomly assigned more than 2,100 patients to receive 3 mg or 6 mg plecanatide or placebo once daily for 12 weeks.

Compared with placebo, both doses of plecanatide resulted in a significantly greater proportion of overall responders — defined by the FDA as patients with at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement from baseline — in the same week, for at least half of the 12 treatment weeks. Diarrhea was the most common adverse event in both studies, with the highest rate (5.4%) occurring in the second study’s 3-mg plecanatide group.

The Prescription Drug User Fee Act (PDUFA) date is January 24, 2018, according to a press release. – by Adam Leitenberger

Reference:

Fogel R, et al. Abstract #874k. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosures: Fogel reports no relevant financial disclosures.