Advantage For Synergy’s Plecanatide Over Rival Linzess Holds Up In IBS-C

Plecanatide met the primary endpoint in first Phase III trial in irritable bowel syndrome with constipation, with less incidence of diarrhea than seen in Linzess trials. Synergy is awaiting approval in chronic idiopathic constipation and appears on pace to file an sNDA in IBS-C during the first quarter.

Top-line data for Synergy Pharmaceuticals Inc.’s plecanatide in irritable bowel syndrome with constipation (IBS-C) from the first of two pivotal Phase III trials appears to be confirmation that the guanylyl cyclase C receptor agonist will have the advantage of less incidence of diarrhea than its chief rival, Allergan PLC/Ironwood Pharmaceuticals Inc.’s Linzess.

There was also less incidence of diarrhea versus Linzess (linaclotide), also a GCC agonist, in the Phase III program for plecanatide in chronic idiopathic constipation (CIC), its lead indication. Plecanatide is under review at FDA for CIC with an action date of Jan. 29. (Also see "Synergy Flaunts Constipation Data From Linzess Challenger" - Scrip, 23 May, 2016.) In CIC pivotal studies, plecanatide resulted in diarrhea as a side effect in 5

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