APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy
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Open Access
- 1 March 2019
- journal article
- research article
- Published by Taylor & Francis Ltd in Journal of Pain Research
- Vol. ume 12, 927-943
- https://doi.org/10.2147/jpr.s171013
Abstract
Purpose: Oliceridine is a novel G protein-biased µ-opioid receptor agonist designed to provide intravenous (IV) analgesia with a lower risk of opioid-related adverse events (ORAEs) than conventional opioids. Patients and methods: APOLLO-1 (NCT02815709) was a phase III, double-blind, randomized trial in patients with moderate-to-severe pain following bunionectomy. Patients received a loading dose of either placebo, oliceridine (1.5 mg), or morphine (4 mg), followed by demand doses via patient-controlled analgesia (0.1, 0.35, or 0.5 mg oliceridine, 1 mg morphine, or placebo). The primary endpoint compared the proportion of treatment responders through 48 hours for oliceridine regimens and placebo. Secondary outcomes included a composite measure of respiratory safety burden (RSB, representing the cumulative duration of respiratory safety events) and the proportion of treatment responders vs morphine. Results: Effective analgesia was observed for all oliceridine regimens, with responder rates of 50%, 62%, and 65.8% in the 0.1 mg, 0.35 mg, and 0.5 mg regimens, respectively (all PPConclusion: Oliceridine is a novel and effective IV analgesic providing rapid analgesia for the relief of moderate-to-severe acute postoperative pain compared to placebo. Additionally, it has a favorable safety and tolerability profile with regard to respiratory and gastrointestinal adverse effects compared to morphine, and may provide a new treatment option for patients with moderate-to-severe postoperative pain where an IV opioid is required.Keywords
This publication has 30 references indexed in Scilit:
- Multimodal Analgesia, Current Concepts, and Acute Pain ConsiderationsCurrent Pain and Headache Reports, 2017
- Association of Opioids and Sedatives with Increased Risk of In-Hospital Cardiopulmonary Arrest from an Administrative DatabasePLOS ONE, 2016
- Cost and Quality Implications of Opioid‐Based Postsurgical Pain Control Using Administrative Claims Data from a Large Health System: Opioid‐Related Adverse Events and Their Impact on Clinical and Economic OutcomesPharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 2013
- Recent Advances in Multimodal AnalgesiaAnesthesiology Clinics, 2012
- American Society for Pain Management Nursing Guidelines on Monitoring for Opioid-Induced Sedation and Respiratory DepressionPain Management Nursing, 2011
- Opioid Complications and Side Effects2008
- Management of common opioid-induced adverse effects.2006
- Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysisCurrent Medical Research and Opinion, 2006
- Adverse events associated with postoperative opioid analgesia: A systematic reviewThe Journal of Pain, 2002
- A Simplified Risk Score for Predicting Postoperative Nausea and VomitingAnesthesiology, 1999