ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine

Background: Pain management with conventional opioids can be challenging due to doselimiting adverse events (AEs), some of which may be related to the simultaneous activation of [beta]-arrestin (a signaling pathway associated with opioid-related AEs) and G-protein pathways. The investigational analg...

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Bibliographic Details
Published in:Journal of pain research 2019-11, p.3113
Main Authors: Mace, Sharon E, Hammer, Gregory B, Pan, Peter H, Brzezinski, Marek, Berkowitz, Richard D, Bergese, Sergio D, Beard, Timothy L, Cochrane, Kristina, Habib, Ashraf S, Minkowitz, Harold S, Wase, Linda
Format: Article
Language:English
Subjects:
Acute pain
Analgesia
Analgesics
Care and treatment
Clinical trials
Constipation
Hospital patients
Labels
Medical research
Nausea
Opioids
Pain management
Safety and security measures
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Summary:Background: Pain management with conventional opioids can be challenging due to doselimiting adverse events (AEs), some of which may be related to the simultaneous activation of [beta]-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 [micro]opioid receptor with less recruitment of [beta]-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 [greater than or equal to]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% [greater than or equal to]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 [+ or -] 2.3 at 30 mins from a score of 6.3 [+ or -]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. ClinicalTrials.gov identifier: NCT02656875. Keywords: acute pain, analgesia, patient-controlled, clinical trial
ISSN:1178-7090
1178-7090