Safety evaluation of oliceridine for the management of postoperative moderate-to-severe acute pain

ABSTRACT

Introduction

Opioids for managing postoperative pain are associated with side effects including opioid-induced respiratory depression (OIRD) and gastrointestinal complications. Opioids induce analgesia via G-protein signaling, while adverse effects are mediated by the β-arrestin pathway. Oliceridine is a biased ligand that preferentially activates G-protein signaling over β-arrestin, theoretically reducing adverse effects. Oliceridine has been approved by the Food and Drug Administration to treat acute pain severe enough to require intravenous opioid analgesics.

Areas covered

Preclinical and clinical trials demonstrate the analgesic efficacy of oliceridine. Available evidence suggests that oliceridine may have a lower risk of OIRD and gastrointestinal complications compared to conventional opioids.

Expert opinion

The analgesic efficacy of oliceridine has been evaluated in several clinical trials. However, safety data were obtained from an open-label observational study and studies assessing adverse effects as secondary outcomes, as post-hoc analyses, or from retrospective studies. These may be affected by gaps in detecting adverse events, heterogeneity in the original studies, and the limitations of retrospective studies. Prospective trials examining the safety of oliceridine versus conventional opioids are needed. Studies are also needed to assess the safety and efficacy of oliceridine in obstetric and pediatric populations, and in the context of multimodal analgesia and Enhanced Recovery after Surgery protocols

KEYWORDS:

• Biased ligand
• mu-opioid receptor
• opioid agonist
• TRV130

BOX Drug summary box

Declaration of interest

AS Habib has received research support from Pacira Biosciences, Heron Therapeutics, Trevena Inc., and Avanos Inc. He also served on the Advisory Board for Takeda, Heron Therapeutics, and Trevena Inc, and is a consultant for Trevena Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript has disclosed that in the past 12 months, they have been a consultant to the following opioid manufacturers: Purdue Pharma and Avenue Therapeutics. All other peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Trevena, Inc. provided a scientific accuracy review at the request of the journal editor.