Pharma submits sNDA for IBS-C drug plecanatide.
A supplemental New Drug Application (sNDA) was submitted today for plecanatide (Trulance/Synergy Pharmaceuticals) to treat adults with irritable bowel syndrome with constipation (IBS-C).
Trulance (3mg) was already approved in the United States (US) on Jan. 19, 2017 and is now available in US pharmacies to treat chronic idiopathic constipation (CIC) in adults.
The application was based on data from two randomized, 12-week, double blind, placebo-controlled phase 3 studies involving 2100 patients that evaluated the safety and efficacy of Trulance. The patients had either received the once-daily Trulance tablet (3mg or 6mg) or placebo.
Results showed that both studies met the primary endpoint: “statistical significant in the percentage of patients who were “overall responders” compared to placebo during the 12-week treatment period”.
The most commonly reported adverse event in both studies was diarrhea. In study 1, 3.2% of patients experienced diarrhea with the 3mg dose and 3.7% with the 6mg dose, and in the second study, 5.4% patients had diarrhea with the 3mg dose and 4.3% with the 6mg dose.
“If approved, we believe Trulance will provide an additional, much-needed, new treatment option for people with IBS-C,” said Gary S. Jacob, PhD, Chairman and CEO, Synergy Pharmaceuticals Inc., in a news release.
Synergy Pharmaceuticals is poised to present additional phase 3 data from the 2 IBS-C trials at scientific meetings later in 2017.