The FDA approved Synergy Pharmaceuticals' irritable bowel syndrome with constipation treatment Trulance.
Here's what you should know:
1. The FDA already approved Trulance to treat adults with chronic idiopathic constipation.
2. Researchers studied the drug's effectiveness through two randomized, 12-week, double-blind, placebo-controlled trials. More than 2,100 patients received either a 3 mg or 6 mg dose of Trulance or a placebo. Synergy was only seeking approval for the 3 mg dose.
In both trials, Trulance met its primary endpoints with patients experiencing reduced abdominal pain and increased stool frequency as a result of the treatment.
3. Synergy Pharmaceuticals' CEO Troy Hamilton said, "The IBS-C approval is a pivotal milestone for Synergy, representing the second approved indication for Trulance in the past 12 months. This approval demonstrates our unwavering commitment to provide a safe and effective treatment option for those patients living with these chronic GI disorders."