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

Objectives The clinical utility of conventional IV opioids is limited by the occurrence of opioid‐related adverse events. 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, ra...

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Bibliographic Details
Published in:Pain practice 2019-09, Vol.19 (7), p.715-731
Main Authors: Singla, Neil K., Skobieranda, Franck, Soergel, David G., Salamea, Monica, Burt, David A., Demitrack, Mark A., Viscusi, Eugene R.
Format: Article
Language:English
Subjects:
Abdominoplasty
Acute Pain - drug therapy
Adult
analgesia
Analgesia, Patient-Controlled
Analgesics - therapeutic use
Analgesics, Opioid - therapeutic use
clinical trial
Double-Blind Method
Female
Humans
Male
Middle Aged
Morphine - administration & dosage
Original
Pain Management
Pain Measurement
Pain, Postoperative - drug therapy
patient controlled
postoperative
Receptors, Opioid, mu
Spiro Compounds - pharmacology
Thiophenes - pharmacology
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Summary:Objectives The clinical utility of conventional IV opioids is limited by the occurrence of opioid‐related adverse events. 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. Methods 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 over 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 vs. morphine. Results A total of 401 patients were treated with study medication. Effective analgesia was observed for all oliceridine regimens, with responder rates of 61.0%, 76.3%, and 70.0% for the 0.1‐, 0.35‐, 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 
ISSN:1530-7085
1533-2500
DOI:10.1111/papr.12801