Trulance sNDA in IBS-C accepted for review by FDA

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

Trulance, a guanylate cyclase-C agonist already indicated for chronic idiopathic constipation, could also be approved in IBS-C by January 24 2018, which is the Prescription Drug User Fee Act date for the sNDA.

Gary Jacob, chairman and chief executive of USA-based Synergy Pharmaceuticals, said: “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.