APOLLO-2: 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 Abdominoplasty.

APOLLO-2: 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 Abdominoplasty.

Publication date: Jun 04, 2019

The clinical utility of conventional intravenous opioids is limited by the occurrence of opioid-related adverse events (ORAEs). Oliceridine is a novel G protein-biased μ-opioid receptor agonist designed to provide analgesia with an improved safety and tolerability profile. This phase III, double-blind, randomized trial [APOLLO-2 (NCT02820324)] evaluated the efficacy and safety of oliceridine for acute pain following abdominoplasty.

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) with a 6-minute lockout interval. The primary endpoint was the proportion of treatment responders through 24 hours for oliceridine regimens compared to placebo. Secondary outcomes included a predefined composite measure of respiratory safety burden (RSB, representing the cumulative duration of respiratory safety events) and the proportion of treatment responders versus morphine.

Effective analgesia was observed for all oliceridine regimens, with responder rates of 61.0%, 76.3%, and 70.0% for the 0.1 mg, 0.35 mg and 0.5 mg regimens, respectively, compared with 45.7% for placebo (all P 0.05 vs. placebo: 0.60 [2.82]). The RSB measure for morphine was 1.72 [3.86] (P

Oliceridine is a safe and effective IV analgesic for the relief of moderate-to-severe acute postoperative pain in patients undergoing abdominoplasty. Since the low dose regimen of 0.1 mg oliceridine was superior to placebo but not as effective as the morphine regimen, safety comparisons to morphine are relevant only to the two equianalgesic dose groups of 0.35 mg and 0.5 mg, which showed a favorable safety and tolerability profile regarding respiratory and gastrointestinal adverse effects compared to morphine. These findings support that oliceridine may provide a new treatment option for patients with moderate-to-severe acute pain where an IV opioid is warranted. This article is protected by copyright. All rights reserved.

Concepts Keywords
Abdominoplasty Nausea
Analgesia Abdominoplasty
Analgesic Opioids
Double Blind Organic compounds
Gastrointestinal Chemical compounds
Intravenous Morphinans
Lockout Analgesics
Morphine RTT
Nausea Euphoriants
Opioid Oliceridine
Opioid Receptor Agonist Morphine
Opioids Equianalgesic
Pain Heroin
Phase III Trevena Inc
Placebo
Primary Endpoint
Protein
Randomized Trial
Tolerability
Vomiting

Semantics

Type Source Name
gene UNIPROT HGS
gene UNIPROT SRSF5
gene UNIPROT HARS
gene UNIPROT ATN1
drug DRUGBANK Morphine
disease DOID analgesia
gene UNIPROT DCLRE1B

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