Synergy’s plecanatide receives FDA approval: 5 key facts

Ahead of its stock offering, the FDA approved New York City’s Synergy Pharmaceuticals Inc.’s plecanatide.

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Here’s what you should know.

1. Plecanatide, or its commercial name Trulance, treats chronic idiopathic constipation in adults.

2. Synergy says plecanatide is the first drug designed to “replicate the function of uroguanylin.”

3. Trulance completed two phase III clinical trials, with diarrhea being the most common adverse reaction.

4. Synergy plans to file a new drug application supplement with clinical data in the second quarter 2017.

5. Gary S. Jacob, Ph.D., chairman and CEO of Synergy Pharmaceuticals Inc., said. “We are thrilled with the approval of Trulance because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their healthcare providers manage this condition. I am confident that we truly have the right team with the right strategic vision and the right launch plan to successfully bring Trulance into this large but underserved market.”

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