New topline Olinvyk data highlighting reduced cost per admission from ARTEMIS real-world outcomes study – Trevena Inc

Trevena, Inc. announced new topline Olinvyk data from the ARTEMIS study.

The ARTEMIS study was an electronic medical records (EMR) based assessment focused on clinical and health resource utilization outcomes at Cleveland Clinic and Wake Forest Baptist Health. The study reviewed Olinvyk-treated patients in the ~200 patient VOLITION study with comparable surgical patients (matched patients) treated with other IV opioids, at the same institutions and during the study period. New topline data includes data from Olinvyk-treated patients (n=105) and matched patients (n=525) at Cleveland Clinic, as well as measures of cost per admission at both Wake Forest Baptist Health and Cleveland Clinic for Olinvyk-treated and matched patients. Initial ARTEMIS data from Wake Forest Baptist Health was previously announced based on Onlivyk-treated patients (n=96) compared to matched patients (n=457) at that site.

“We are pleased that the use of Olinvyk versus other IV opioids demonstrated a statistically significant reduced cost per admission and a reduced average length of stay, which we believe are important considerations as hospitals look to manage resources,” said Carrie Bourdow, President and CEO of Trevena. “These data are consistent with prior health economic analyses we have conducted, and we believe these differences will be meaningful to key healthcare decision makers.”

ARTEMIS (EMR-Based) Topline Results : Overall Data from Cleveland Clinic and Wake Forest Baptist Health. Olinvyk-treated patients (n=201) had a $8,756 (19%) reduction in average cost per admission (p<0.0001) and 1.4-day (20%) reduction in average overall hospital length of stay (p<0.0001) compared to matched patients (n=982) treated with other IV opioids. Based on the data we have to date, there was not a statistically significant difference in the average duration of time in the post-anesthesia care unit (PACU) between Olinvyk-treated and matched patients.

Cleveland Clinic Results. Olinvyk-treated patients (n=105) had a $7,102 reduction in average cost per admission (p=0.00043) and a 0.9-day reduction in average overall hospital length of stay (p=0.0181) compared to matched patients (n=525) treated with other IV opioids at Cleveland Clinc.

Wake Forest Baptist Health Results Olinvyk-treated patients (n=96) had a $10,339 reduction in average cost per admission (p<0.0001) compared to matched patients (n=457) treated with other IV opioids at Wake Forest Baptist Health. The Company previously announced that Olinyk-treated patients at this site had a 1.6 day reduction in average overall hospital length of stay compared to matched patients treated with other IV opioids (p<0.0001).

ARTEMIS Study Details : ARTEMIS is an electronic medical record (EMR) based analysis that compared the health outcomes of VOLITION study patients with a matched population of patients, who underwent similar surgical procedures but were treated with other IV opioids, at the same institutions and during the same general time period as VOLITION. Matching was conducted with a greedy matching algorithm, using a propensity scoring method with eight different demographic and clinical characteristics including age, sex, type and duration of surgery, measures of overall surgical and medical morbidity, and type of hospital insurance. Cost weights were calculated using a national dataset, and data was controlled for relevant covariates.

The Company previously announced initial topline ARTEMIS data from Wake Forest Baptist Health (n=96 Olinvyk-treated patients; n=457 matched patients treated with other IV opioids). New topline data is now available from Cleveland Clinic (n=105 Olinvyk treated patients; n=525 matched patients treated with other IV opioids), as well as for cost per admission for both Wake Forest Baptist Health and Cleveland Clinic. While an EMR analysis does not provide definitive data of group differences as seen in a prospectively randomized study, we believe EMR data bring a unique perspective to an understanding of how drugs may perform in the real world.

VOLITION Study Details ; VOLITION is a real-world, open-label, multi-site, post-approval clinical outcomes study in 203 adult patients undergoing major non-cardiac surgery. IV Olinvyk was dosed as the first-line analgesic during post-operative care, with a 1.5mg loading dose of Olinvyk at surgical closure, and 0.35mg to 0.5mg of Olinvyk, as needed, administered with a PCA device, with a 6-minute lockout period. Additional boluses ( less than 1 mg) of Olinvyk were available if needed as soon as 15 minutes after the initial 1.5 mg loading dose. The average age of patients in VOLITION was 57.1 years (range 19 to 89), with approximately equal representation of men and women. Approximately 85% of patients underwent an abdominal surgical intervention, such as partial or total colectomy, enterotomy or other open abdominal procedures. A majority of patients had significant morbidity at the time of surgery as reflected by ASA status, and their respiratory risk was intermediate to high risk, graded using the PRODIGY risk score. The average duration of the surgery was 4.7 hours (range of 1.2 to 12.6 hours).