--
Elderly and obese patients receiving OLINVYK are not at increased risk for respiratory depression, compared to younger and non-obese patients, based on exploratory analysis
--
The poster highlights an exploratory analysis of respiratory safety data from the OLINVYK Phase 3 multi-site, open-label, “real world” study. The incidence of opioid-induced respiratory depression (OIRD) was similar between “high-risk” patients, defined as elderly and obese, and “low-risk” patients, defined as younger and non-obese. This lack of difference was observed despite the high-risk group having a higher average age, average BMI, comorbid burden, mean cumulative dose, and mean duration of exposure to OLINVYK. Advanced age and obesity are two well-recognized risk factors for developing OIRD.
“Complex patients with medical comorbidities pose unique challenges in postoperative pain management, due to their increased risk for developing adverse events such as respiratory depression,” said
Poster Details
“Low Incidence of Opioid-Induced Respiratory Depression Observed with Oliceridine In High-Risk Elderly Obese Patients” (Poster #979,
- High-risk patients (n=120) demonstrated a relatively low OIRD incidence of 10.8%, which was numerically lower than the OIRD incidence of 14.6% in low-risk patients (n=268) and 12.9% in all patients.
- Out of 768 patients in the study, 33% were ≥ 65 years of age and 46% had a BMI of ≥ 30 kg/m2. The average age in the high-risk group was 70 vs. 45 years in the low-risk group. The average BMI in the high-risk group was 35.6 kg/m2 vs. 25.1 kg/m2 in the low-risk group.
- The mean cumulative dose of OLINVYK was 37.1 mg in the high-risk group vs. 30 mg in the low-risk group. The mean duration of exposure was 39.8 hours in the high-risk group vs. 28.1 hours in the low-risk group.
- There was a higher incidence of other medical comorbidities in the high-risk group, including asthma, sleep apnea, chronic obstructive pulmonary disease, diabetes, and hypertension, which are also known to increase the risk of OIRD.
- OIRD was defined by administration of naloxone, a respiratory rate <10 bpm, or oxygen saturation < 90%. No naloxone administration was required for any patient treated with OLINVYK in the study.
The poster can be found at https://www.trevena.com/publications.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in
About Trevena
For more information, please visit www.Trevena.com
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the
For more information, please contact:
Investor Contact:
Managing Director
daniel@lifesciadvisors.com
(617) 430-7576
PR & Media Contact:
Director
Sasha.Bennett@clydegroup.com
(239) 248-3409
Source:
2021 GlobeNewswire, Inc., source