The government's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is meeting all day to review oliceridine, a product developed by Trevena for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted.
Trevena’s New Drug Application (NDA) submission for oliceridine was accepted by the FDA on January 2, 2018, with a PDUFA target date for completion of review by the FDA of November 2, 2018.
The AADPAC reviews and evaluates available data concerning the safety and effectiveness of marketed drug products for use in anesthesiology and surgery and makes recommendations to the FDA.
The FDA is not bound by the Advisory Committee’s recommendations but takes its advice into consideration when making its decisions.
Oliceridine is a G-protein biased mu-opioid receptor (MOR) ligand in development to manage moderate to severe acute pain in hospitals or other controlled clinical settings and where intravenous (IV) therapy is justified.
Shares of Trevena were trading very early in the premarket on Thursday at $0.94, having closed on Wednesday 11.5% down at $0.947.
Trevena is a biopharmaceutical company focused on the development and commercialization of new treatment options for patients in pain.
The company is based in Chesterbrook, Pennsylvania.