Form 8-K TREVENA INC For: Mar 05
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Trevena (TRVN) says FDA informed it that data were not sufficient to support continuation of previously granted Breakthrough Therapy designation for oliceridine
March 7, 2019 4:32 PM ESTTrevena (NASDAQ: TRVN) disclosed in an SEC filing:
In February 2016, based on the preliminary evidence from Trevenas (the Company) Phase 2 clinical studies of oliceridine, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to oliceridine for the management of moderate to severe acute pain. Breakthrough Therapy designation is granted by the FDA to new therapies intended to treat serious or life-threatening conditions and for which preliminary... More
