NEW YORK, — Levi & Korsinsky announces it has commenced an investigation of Trevena, Inc. (“Trevena” or “the Company”) (NASDAQGS: TRVN) concerning possible violations of federal securities laws.
On May 2, 2016, Trevena announced it had “reached general agreement” with the U.S. Food and Drug Administration concerning key elements of its Phase 3 program for oliceridine (TRV130). Then the FDA released a briefing document in advance of its October 11, 2018 vote on the efficacy and safety of the treatment; in this briefing document the reviewers noted that oliceridine has abuse and overdose potential. In fact, according to the notes from the previous meeting, the FDA “did not agree with the proposed dosing in the Phase 3 studies,” the proposed primary endpoint, or the “proposed non-inferiority (NI) margin for comparing morphine to oliceridine.” Following this news, shares of Trevena fell more than 64% on October 9, 2018. To obtain additional information, go to:
or contact Joseph E. Levi, Esq. either via email at [email protected] or by telephone at (212) 363-7500, toll-free: (877) 363-5972.
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