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Synergy Flaunts Constipation Data From Linzess Challenger

 
• By Sukaina Virji

Synergy Pharmaceuticals, which is waiting on a decision from the US FDA on its constipation drug plecanatide, provided additional data from two pivotal Phase III trials at Digestive Disease Week (DDW) in San Diego recently. The product will go up against Linzess, which is marketed by Allergan and Ironwood Pharmaceuticals, and is expected to compete on its better side effect profile.

Constipation
• Source: Shutterstock

Synergy Pharmaceuticals Inc.filed for FDA approval in January this year for the once-daily tablet plecanatide, a uroguanylin analog, as a treatment for chronic idiopathic constipation (CIC). The NDA has been accepted for FDA review with a PDUFA target action date of January 29, 2017.

The plecanatide NDA was supported by two double-blind placebo-controlled Phase III trials (Study-00 and Study-03) and one open-label long term safety study. A total of more than 2,700 patients with...

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