FDA accepts Synergy's supplemental new drug application for Trulance to treat IBS-C — 3 key notes

The FDA accepted Trulance Pharmaceutical's supplemental new drug application for the treatment of irritable bowel syndrome with constipation.

Here's what you should know:

1. The FDA previously approved Trulance for the treatment of adults with chronic idiopathic constipation. The FDA is evaluating how adults with IBS-C respond to Trulance.

2. In two phase III clinical trials, both 3 mg and 6 mg doses of Trulance were statistically significant compared to a placebo when used to treat IBS-C.

3. Synergy Pharmaceutical's CEO Gary Jacobs, PhD, said in a release, "This acceptance by the FDA is an important step forward for Synergy, building on the recent FDA approval and launch of Trulance for adults with CIC, and signaling the next step in our efforts to bring Trulance to the many millions of people living with IBS-C."

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