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.

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.

Publication date: Mar 19, 2019

Oliceridine is a novel G protein-biased u-opioid receptor agonist designed to provide intravenous (IV) analgesia with a lower risk of opioid-related adverse events (ORAEs) than conventional opioids.

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.

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 P

Open Access PDF

Viscusi, E.R., Skobieranda, F., Soergel, D.G., Cook, E., Burt, D.A., and Singla, N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the u-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. 03628. 2019 J Pain Res (12):

Concepts Keywords
Analgesia Trevena Inc
APOLLO 1 Heroin
Double Blind Placebo
Intravenous Morphine
Ligand Oliceridine
Morphine Analgesics
Opioid Euphoriants
Opioid Receptor RTT
Opioid Receptor Agonist Morphinans
Opioids Chemical compounds
Pain Organic compounds
Phase III Opioids
Placebo Orthopedic surgery
Primary Endpoint
Protein
Randomized Trial

Semantics

Type Source Name
drug DRUGBANK Morphine
disease DOID analgesia
gene UNIPROT DCLRE1B

Similar

Original Article

Leave a Comment

Your email address will not be published. Required fields are marked *