Trevena, Inc. Announces Three OLINVYK Presentations at the Virtual American Society of Anesthesiologists 2020 Annual Meeting - Seite 2

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.

3. (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.

About OLINVYK (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.