FDA approves Synergy Pharmaceuticals' Trulance for adults with IBS-C — 3 insights

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."

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