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BRIEF-Synergy Pharmaceuticals says positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation
December 22, 2016 / 9:51 PM / 9 months ago

BRIEF-Synergy Pharmaceuticals says positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation

Dec 22 (Reuters) - Synergy Pharmaceuticals Inc

* Synergy Pharmaceuticals announces positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation (ibs-c)

* Synergy Pharmaceuticals Inc - plecanatide is under review by food and drug administration (fda) for treatment of chronic idiopathic constipation

* Synergy Pharmaceuticals - most common adverse event was diarrhea which occurred in 5.4 pct of patients in 3 mg and 4.3% of patients in 6 mg dose groups

* Synergy Pharmaceuticals Inc - overall responder endpoint is current regulatory endpoint required for U.S. approval in ibs-c

* Preliminary analysis of data indicates that both plecanatide 3 mg and 6 mg doses met study’s primary endpoint

* Synergy Pharmaceuticals- pending approval in cic indication,plans to file new drug application supplement with clinical data for plecanatide in ibs-c in q1 2017

* Synergy Pharmaceuticals Inc - prescription drug user fee act (pdufa) target action date for plecanatide is January 29, 2017

* Synergy Pharmaceuticals says it plans to present further clinical data from both trials at an appropriate scientific meeting next year

* Synergy Pharmaceuticals announces positive results in second phase 3 trial of plecanatide in patients with irritable bowel syndrome with constipation (ibs-c) Source text for Eikon: Further company coverage:

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