New York City-based Synergy Pharmaceuticals submitted a supplemental New Drug Application for Trulance.
Here's what you should know.
1. Trulance was FDA approved in adults with chronic idiopathic constipation on Jan. 19, 2017. Synergy is submitting the supplemental application to earn FDA approval for using Trulance to treat irritable bowel syndrome with constipation.
2. Synergy conducted two randomized, 12-week, double-blind, placebo-controlled phase III studies on Trulance's efficacy and safety in IBS-C-positive adults.
3. Trulance met its primary endpoints in both trials, showing statistical significance in patients with IBS-C. The most common adverse event was diarrhea.
4. Synergy CEO Gary Jacob, PhD, said in a release, "“Following the successful launch of TRULANCE in CIC, the submission of this supplemental application marks another important milestone for Synergy in our ongoing quest to bring new treatments that address significant unmet medical needs to patients living with GI disorders."
5. Synergy will present additional data on Synergy's phase III trials at scientific meetings later in 2017.