CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN), announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on October 11, 2018 in Silver Spring, MD, to discuss the safety and efficacy of oliceridine injection for the management of moderate to severe acute pain.
The Company‘s New Drug Application (NDA) submission for oliceridine was accepted for review by the FDA on January 2, 2018. The Prescription Drug User Fee Act (PDUFA) target date for completion of review by FDA of November 2, 2018 remains unchanged.
“We look forward to the Advisory Committee meeting on October 11 and the opportunity to present our perspectives on the oliceridine clinical data and its potential role in treating moderate to severe acute pain,” said Maxine Gowen, President and Chief Executive Officer. “We remain committed to working closely with the FDA towards achieving the goal of ensuring hospital patients who require an IV opioid to manage their moderate to severe acute pain have access to effective and safe treatment options.”
Members of the Anesthetic and Analgesic Drug Products Advisory Committee will review and evaluate available data regarding safety and effectiveness and make appropriate recommendations. All final decisions will be made by the FDA.
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA, 19087
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