Trevena Inc (NASDAQ: TRVN) commenced a clinical trial evaluating OLINVYK’s physiological impact on respiratory function in obese and elderly subjects.
A leading clinical researcher and professor (Anesthesiology) – Albert Dahan, is leading this evaluation study. It is based on the previously completed work executed by the company in collaboration with Dahan’s research team.
Dahan said Clinical utility function analysis allows a precise way to evaluate different medication effects on multiple drugs such as respiratory depression and analgesia. Therefore, the team can assess risk versus benefit.
Dahan further said OLINVYK showed an impressive clinical benefit over IV morphine across various plasma concentrations during his previous work. He is thrilled to build upon this previous activity and study OLINVYK in a broad population of individuals relevant to its use.
Enrolls subjects 55 years or old
The company would enroll people aged 55 years or older, in this double-blind, randomized phase 1 clinical trial.
It plans to induct 50% of the people aged 65 years and old and around 30% of people with BMI more than 30 kg/m2. The company will administer all the people with two doses of IV morphine and two doses of OLINVYK to get a wide range of plasma concentrations that are clinically relevant for each medication.
It will assess respiratory depression with the help of VRS measure. Also, it will use a cold pressor test to measure analgesia. The company will assess both the treatments ventilator and analgesic effects via population PD/ PK modeling/ clinical utility function analysis in this clinical study.
Trevena expects to commence enrollment of patients in Q3 2021 and publish topline data by the end of this year.
Trevena’s CMO, Mark A. Demitrack, said he is thrilled to collaborate with Dahan as the company advances its post-approval developmental plan for its OLINVYK. Its main objective is to demonstrate the evidence for the differentiated OLINVYK clinical profile. Mark further said physiologic data generated from this clinical trial would help to strengthen the therapeutic potential of OLINVYK to cure acute pain.
The US FDA approved the new chemical entity – OLINVYK, which comprises oliceridine, in August 2020.
Oliceridine is a schedule II controlled substance. Users can abuse this drug. It is recommended for the treatment of acute pain in adults.