CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) announced Wake Forest Baptist Health Medical Center will join the VOLITION (“Intravenous Oliceridine and Opioid Related Complications”) study which examines the impact of OLINVYK (oliceridine) injection on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting. Ashish K. Khanna, FCCM, FCCP, M.D., Associate Professor of Anesthesiology, Wake Forest School of Medicine, will serve as the lead investigator at this hospital.
“I am pleased to welcome Wake Forest to our collaboration as we continue to strengthen the body of evidence underlying the unique clinical profile of OLINVYK,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. “We believe the safety and tolerability outcomes data that we will generate from this study will demonstrate additional areas of significant clinical need where OLINVYK may add value.”
The VOLITION study is an open-label, multi-site study being led by clinical outcomes research experts from Cleveland Clinic. Respiratory safety will be assessed by continuous monitoring. Additional outcomes will include GI tolerability as measured by GI complete response, and cognitive function as measured by standardized somnolence, sedation, and delirium assessment scales. The study is expected to enroll approximately 200 adults undergoing major surgery. Patient enrollment is expected to begin in Q3 2021.
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