CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, announced three presentations at ANESTHESIOLOGY® 2020, the national conference for the American Society of Anesthesiologists (ASA). The conference was held virtually from October 2nd to 7th, 2020. The presentations included three posters, all of which discussed new analyses of data from the OLINVYK Phase 3 program.
“Throughout its clinical development, OLINVYK has demonstrated a consistently favorable side effect profile,” said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. “I am pleased that we are still gaining valuable clinical insights into its differentiated profile as we continue to examine the robust Phase 3 data, which is clearly of great interest to clinicians looking for alternative treatment options for the treatment of acute pain.”
- (Poster #A4280) “Evaluating Predictive Value Of Postoperative O2 Saturation Levels To Rate Of Respiratory Safety Events In Oliceridine Trials,” with lead author Sabry Ayad, M.D., Department of Anesthesiology at Cleveland Clinic.
- OLINVYK demonstrated an overall lower incidence of respiratory safety events (RSEs) (12.8% – 13.8%) compared with IV morphine (22.8% – 23.4%) in Phase 3 randomized controlled trials (RCTS) in orthopedic and plastic surgeries.
- In these OLINVYK Phase 3 RCTs, respiratory safety was assessed using a predefined RSE measure. An analysis was conducted to determine the correlation between RSEs and oxygen saturation (SpO2) < 90%, a known independent risk factor of early postoperative respiratory complications and resource utilization.
- The analysis showed that SpO2 < 90% was predictive of an RSE and may serve as a valuable objective measure within a health economic model for OLINVYK.
- (Poster #A4281) “Improved Tolerability With Oliceridine Compared To Morphine At Equianalgesic Doses,” with lead author Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University.
A secondary analysis was conducted on the data from the OLINVYK Phase 3 pivotal RCTs in order to evaluate the safety of OLINVYK, compared to IV morphine, when adjusted for equal levels of analgesia. A composite safety endpoint was defined using the adverse events (AEs) that occurred in ≥ 10% of patients who received either OLINVYK or IV morphine (nausea, vomiting, sedation, dizziness, pruritus, and hypoxia). The incidence of the individual AEs was also assessed.
- Following orthopedic surgery, OLINVYK demonstrated a significantly lower odds ratio (p < 0.05) for rates of nausea, vomiting, and pruritus, compared to IV morphine.
- Following plastic surgery, OLINVYK demonstrated a significantly lower odds ratio (p < 0.05) for rates of nausea, vomiting, and sedation compared to IV morphine.
- At equianalgesic levels, OLINVYK’s odds ratio for the composite safety endpoint was approximately half of that associated with IV morphine. The findings were consistent across both studies.
- (Poster #A4284) “Reduced Incidence Of Postoperative Vomiting With Oliceridine Than Morphine At Equianalgesic Doses,” with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group.
A retrospective analysis was conducted on the gastrointestinal (GI) tolerability data from the OLINVYK Phase 3 RCTs, using a ‘complete GI response’ endpoint. A ‘complete GI response’ is defined as the proportion of patients who complete the study without vomiting and without using any anti-emetics.
- In both studies, OLINVYK 0.1 mg and 0.35 mg were associated with a significantly higher rate of ‘complete GI response’ compared with IV morphine.
- Under equianalgesic conditions, where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, the odds ratio for ‘complete GI response’ was higher with OLINVYK than IV morphine.
All posters can be found at https://www.trevena.com/publications.
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