CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) announced two presentations at ANESTHESIOLOGY® 2021, the national conference for the American Society of Anesthesiologists (ASA). Both posters highlighted safety data from the OLINVYK (oliceridine) injection program. The meeting was held on October 8th to 12th in San Diego, California.
“I am pleased that we continue to expand the published database underlying OLINVYK’s compelling product profile,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. “The robust data that we have generated in clinically complex patients will continue to serve as valuable information for healthcare providers as they consider the use of OLINVYK in their post-operative patients.”
- E-Poster #1: “Elevated Body Mass Index Does Not Affect Adverse Events Associated With Oliceridine, An Intravenous Opioid Agonist” with lead author Joseph F. Answine, M.D., Assistant Professor of Anesthesiology, Penn State Health Milton S. Hershey Medical Center.This poster reports the incidence of opioid-related adverse events (ORAEs), stratified by BMI categories (<30 kg/m2, 30-40 kg/m2 and >40 kg/m2), from the OLINVYK Phase 3 real world open-label safety study. In the post-operative setting, obesity is a known risk factor for developing ORAEs.
- Obese patients (BMI > 30 kg/m2) were not at an increased risk for developing ORAEs, despite having a higher incidence of medical comorbidities compared to non-obese patients.
- In the study, 46% (352/768) of patients were obese, and 10% of patients were morbidly obese (BMI > 40 kg/m2).
- Selected by ASA’s Committee on Scientific Advisory for inclusion in a special in-person poster session on October 9th.
- E-Poster #2: “Safety Of Intravenous Oliceridine In Patients With Renal Impairment: Findings From A Phase 3 Open-label Study” with lead author Ashraf S. Habib, M.D., Professor of Anesthesiology, Duke University School of Medicine.This poster reports the incidence of ORAEs and opioid-induced respiratory depression (OIRD), defined by oxygen saturation (SpO2) < 90% or respiratory rate (RR) < 10 bpm, in patients with renal impairment from the OLINVYK Phase 3 real-world open-label safety study. In the post-operative setting, patients with renal impairment are at a high risk of developing serious ORAEs, and dosage adjustment is often required when administering IV opioids.
- Patients with moderate to severe renal insufficiency, defined as stage 3 or higher chronic kidney disease (CKD), were not at an increased risk for developing ORAEs or OIRD, compared to patients with stage 1-2 CKD.
- Among all study patients, none experienced SpO2 < 90% and RR < 10 bpm at the same time, and no patients received naloxone during treatment with OLINVYK.
- In the study, nearly 18% (137/768) of patients had stage 3 or higher CKD.
All posters can be found at https://www.trevena.com/publications.
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