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

Viscusi, Eugene R; Skobieranda, Franck; Soergel, David G; Cook, Emily; Burt, David A; Singla, Neil

doi:10.2147/jpr.s171013

Cited by 169Pain Management and Opioid UseAnesthesia and Pain ManagementOpioid Use Disorder Treatment

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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Viscusi, Eugene R, Skobieranda, Franck, Soergel, David G, Cook, Emily, Burt, David A, Singla, Neil·2019·Journal of Pain Research

DOI 10.2147/jpr.s171013PMC PMC6417853

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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 P <0.0001 vs placebo [15.2%]; 0.35 mg and 0.5 mg non-inferior to morphine). RSB showed a ose-dependent increase across oliceridine regimens (mean hours [SD]: 0.1 mg: 0.04 [0.33]; 0.35 mg: 0.28 [1.11]; 0.5 mg: 0.8 [3.33]; placebo: 0 [0]), but none were statistically different from morphine (1.1 [3.03]). Gastrointestinal adverse events also increased in a dose-dependent manner in oliceridine regimens (0.1 mg: 40.8%; 0.35 mg: 59.5%; 0.5 mg: 70.9%; placebo: 24.1%; morphine: 72.4%). The odds ratio for rescue antiemetic use was significantly lower for oliceridine regimens compared to morphine ( P <0.05). Conclusion: 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: postoperative, analgesia, patient controlled, clinical trial, orthopedic surgery

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Oliceridine is a biased μ-opioid receptor ligand with comparable analgesic effects to morphine.
“Oliceridine is a biased µ-opioid receptor ligand with comparable analgesic effects to morphine”
From Irritable bowel syndrome (2020) · cites this paper as [147]
There are no human studies of oliceridine in visceral pain.
“although there are, as yet, no human studies in visceral pain”
From Irritable bowel syndrome (2020) · cites this paper as [147]
The Introduction describes human studies in healthy volunteers and patients undergoing bunionectomy or abdominoplasty, but does not address whether any human studies of oliceridine in visceral pain existed. A search for visceral pain and abdominal pain found no passage establishing that absence. Page numbers are unavailable in our copy. (LLM, conf=0.72)
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(223) APOLLO-1: randomized, placebo- and active-controlled phase 3 study investigating oliceridine (TRV130), a novel μ receptor G protein Pathway Selective (μ-GPS) modulator, for management of moderate to severe acute pain following bunionectomy
Skobieranda, F. G., Singla, N., Burt, D. A., & Soergel, D. G. (2017) · Journal of Pain · doi:10.1016/j.jpain.2017.02.115 · Cited by 5 · see citing works
Self-citation
APOLLO-1: a Randomized, Controlled, Phase 3 Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Pain Following Bunionectomy
Singla, N., Senagore, A. J., Viscusi, E. R., Burt, D. A., & Soergel, D. G. (2017) · The Spine Journal · doi:10.1016/j.spinee.2017.08.071 · Cited by 4 · see citing works
Self-citation
APOLLO‐2: A Randomized, Placebo and Active‐Controlled Phase III Study Investigating Oliceridine ( TRV 130), a G Protein–Biased Ligand at the μ‐Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty
Singla, N., Skobieranda, F. G., Soergel, D. G., Salamea, M., Burt, D. A., Demitrack, M. A., & Viscusi, E. R. (2019) · Pain Practice · doi:10.1111/papr.12801 · Cited by 185 · see citing works
Self-citation
A randomized double-blind placebo-controlled trial of oliceridine, a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy
Kim, S., Cho, B. K., Young, K.-W., Sung, K.-S., Lee, Y. K., Ahn, J., Kim, B. S., Kang, C., Lee, K., Park, C. H., et al. (2026) · Current Medical Research and Opinion · doi:10.1080/03007995.2026.2632422
I1. A Randomized, Placebo- and Active-Controlled Phase 2b Study Investigating Oliceridine (TRV130)
Soergel, D. G., Minkowitz, H. S., Burt, D. A., & Skobieranda, F. G. (2017) · Pain Management Nursing · doi:10.1016/j.pmn.2017.02.191
Self-citation

Authors: Viscusi, E. R., Skobieranda, F., Soergel, D. G., Cook, E., Burt, D. A., & Singla, N.
Affiliations: Thomas Jefferson University (US)
Trevena, Inc. (United States) (US)
Lotus Clinical Research (US)
Corresponding author: Viscusi, Eugene R
ORCID: Viscusi, Eugene R
Burt, David A
Singla, Neil
Venue: Journal of Pain Research
Publisher: Informa UK Limited
Published: 2019-03
Volume: Volume 12
Pages: 927-943
ISSN: 1178-7090 (ISSN-L)
DOI: 10.2147/jpr.s171013
PMC: PMC6417853
OpenAlex: W2921387917
Cited by: 167
References: 33
Citations by year: 2026: 29 · 2025: 23 · 2024: 14 · 2023: 10 · 2022: 22 · 2021: 32 · 2020: 25 · 2019: 12
FWCI: 32.35
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by-nc
creativecommons.org/licenses/by-nc/3.0/ (unspecified)
Locations: Journal of Pain Research (publishedVersion, cc-by-nc)
Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Dove Medical Press (Taylor and Francis Group) (acceptedVersion, other-oa)
DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
Funders: American Society of Colon and Rectal Surgeons
American Pain Society
Topics: Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
Health Sciences › Medicine › Surgery › Anesthesia and Pain Management
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Keywords: oliceridine, TRV130, mu-opioid receptor agonists, postoperative pain, bunionectomy, morphine, patient-controlled analgesia, opioid side effects, respiratory safety, gastrointestinal adverse effects, antiemetic use, analgesic efficacy, dose-response relationship, non-inferiority, intravenous analgesia

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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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