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ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The μ-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy

Authors Bergese SD, Brzezinski M, Hammer GB, Beard TL, Pan PH, Mace SE, Berkowitz RD, Cochrane K, Wase L, Minkowitz HS, Habib AS

Received 30 May 2019

Accepted for publication 19 October 2019

Published 14 November 2019 Volume 2019:12 Pages 3113—3126


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Katherine Hanlon

Sergio D Bergese,1 Marek Brzezinski,2 Gregory B Hammer,3 Timothy L Beard,4 Peter H Pan,5 Sharon E Mace,6 Richard D Berkowitz,7 Kristina Cochrane,8 Linda Wase,8 Harold S Minkowitz,9 Ashraf S Habib10

1School of Medicine, Stony Brook University, Stony Brook, NY, USA; 2School of Medicine, University of California San Francisco, VA Medical Center, San Francisco, CA, USA; 3Stanford University School of Medicine, Stanford, CA, USA; 4Clinical Research, Summit Medical Group/Bend Memorial Clinic, Bend, OR, USA; 5Wake Forest School of Medicine, Winston-Salem, NC, USA; 6Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, Cleveland, OH, USA; 7Phoenix Clinical Research, Tamarac, FL, USA; 8Trevena, Inc., Chesterbrook, PA, USA; 9HD Research Corporation, Houston, TX, USA; 10Duke University Medical Center, Durham, NC, USA

Correspondence: Sergio D Bergese
School of Medicine, Stony Brook University, Health Sciences Center, Level 4, Room 060, Stony Brook, NY 11794, USA
Tel +1 631-444-2979
Fax +1-631-444-2907

Background: Pain management with conventional opioids can be challenging due to dose-limiting adverse events (AEs), some of which may be related to the simultaneous activation of β-arrestin (a signaling pathway associated with opioid-related AEs) and G-protein pathways. The investigational analgesic oliceridine is a G-protein-selective agonist at the μ-opioid receptor with less recruitment of β-arrestin. The objective of this phase 3, open-label, multi-center study was to evaluate the safety and tolerability, of IV oliceridine for moderate to severe acute pain in a broad, real-world patient population, including postoperative surgical patients and non-surgical patients with painful medical conditions.
Methods: Adult patients with a score ≥4 on 11-point NRS for pain intensity received IV oliceridine either by bolus or PCA; multimodal analgesia was permitted. Safety was assessed using AE reports, study discontinuations, clinical laboratory and vital sign measures.
Results: A total of 768 patients received oliceridine. The mean age (SD) was 54.1 (16.1) years, with 32% ≥65 years of age. Most patients were female (65%) and Caucasian (78%). Surgical patients comprised the majority of the study population (94%), most common being orthopedic (30%), colorectal (15%) or gynecologic (15%) procedures. Multimodal analgesia was administered to 84% of patients. Oliceridine provided a rapid reduction in NRS pain score by 2.2 ± 2.3 at 30 mins from a score of 6.3 ± 2.1 (at baseline) which was maintained to the end of treatment. No deaths or significant cardiorespiratory events were reported. The incidence of AEs leading to early discontinuation and serious AEs were 2% and 3%, respectively. Nausea (31%), constipation (11%), and vomiting (10%) were the most common AEs. AEs were mostly of mild (37%) or moderate (25%) severity and considered possibly or probably related to oliceridine in 33% of patients.
Conclusion: Oliceridine IV for the management of moderate to severe acute pain was generally safe and well tolerated in the patients studied. identifier: NCT02656875.

Keywords: acute pain, analgesia, patient-controlled, clinical trial

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