Trevena (NASDAQ:TRVN) reported data from two real-world outcomes studies evaluating opioid pain drug Olinvyk (oliceridine).
VOLITION:
The study, dubbed VOLITION, enrolled 203 patients. Olinvyk-treated patients had a 52.2% gastrointestinal (GI) complete responder rate, defined as no vomiting and no antiemetic use in the post-operative period.
As reference, in pooled data for the Trevena's phase 3 trials of Olinvyk, the GI complete response rate was 46.2% for 0.35mg dose group and 39.7% for 0.5mg, according to the company.
Over 90% of patients on Olinvyk reported feeling "alert and calm" from the morning of the first post-operative day and at every observation after that, the company added.
Trevena noted that 3.9% on Olinvyk showed symptoms suggesting delirium at any point in the 48-hour post-operative period.
The company said that data for main and secondary respiratory goals and other endpoints were not yet available but it hopes to report these data in mid-2023.
No deaths and no drug-related serious adverse events (SAEs) were seen in the VOLITION study, the company noted.
ARTEMIS:
The ARTEMIS study was an electronic medical records (EMR) based evaluation for clinical and health resource use outcomes. This initial data was from 96 patients treated with Olinvyk and 457 matched patients treated with other IV opioids.
The company said patients on Olinvyk had a statistically significant 1.6 day (~27%) reduction in average overall hospital length of stay, versus matched patients treated with other IV opioids.
However, there was no statistically significant difference in the average duration of time in the post-anesthesia care unit (PACU), with 2.4 hours seen for both Olinvyk group and the other group.
In addition, (4.4%) matched patients experienced delirium or altered consciousness, versus 1 patient (1%) on Olinvyk, but the difference was not statistically significant, as per the company.
Patients on an IV opioid who felt delirium or altered consciousness in the study had an average hospital length stay 10.5 days longer, than patients who did not experience this event, Trevena noted.
Olinvyk, which contains an opioid called oliceridine, was approved by the FDA in August 2020.
TRVN +8.48% to 0.79 premarket March 30