Trevena Announces FDA Acceptance for Review of New Drug Application for OLINVO™ (oliceridine) Injection
CHESTERBROOK, Pa., Jan. 02, 2018 (GLOBE NEWSWIRE) — Trevena, Inc. (NASDAQ:TRVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for OLINVO™ (oliceridine) Injection. The Company expects that the PDUFA date for the NDA will be in the fourth quarter of 2018. OLINVO is an investigational product for the management of moderate to severe acute pain. It is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer associated adverse effects.
“The NDA file acceptance represents another major step in our progress towards delivering OLINVO to patients and healthcare providers in need of new options for managing moderate to severe acute pain in the hospital setting,” said Maxine Gowen, Ph.D., chief executive officer. “We look forward to working with the FDA as they evaluate the OLINVO application.”