Oliceridine


Oliceridine is an opioid drug that is under evaluation in human clinical trials for the intravenous treatment of severe acute pain. It is a μ-opioid receptor biased agonist developed by Trevena. In cell-based research, oliceridine elicits robust G protein signaling, with potency and efficacy similar to that of morphine, but with less β-arrestin 2 recruitment and receptor internalization. However, recent reports highlight that this might be due to its low intrinsic efficacy, rather than functional selectivity or 'G protein bias' as initially reported. In vivo, it may have fewer adverse effects compared with morphine. In general, in vitro potency does not guarantee any clinical relevance in humans.

Society and culture

An FDA advisory committee voted against the approval of oliceridine in 2018, due to concerns that the benefit of the drug did not exceed the risk. The risks of oliceridine include prolongation of the QT interval on the ECG, and depression of the respiratory drive. As a result of the committee's vote, the FDA declined to approve oliceridine, citing safety concerns.
Oliceridine is seeking approval again from the FDA. A decision is expected before August 8, 2020.
https://d1io3yog0oux5.cloudfront.net/_1c2f78c1906a4e4e81ecc8b67dfbd4d1/trevena/db/707/6063/pdf/TRVN_overview_nonconf_60820_vF.pdf