Oliceridine for the Management of Moderate to Severe Acute Postoperative Pain: A Narrative Review

References

• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014;30(1):149–160. doi:10.1185/03007995.2013.860019
   PubMed Web of Science ®Google Scholar
• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97(2):534–540. doi:10.1213/01.ANE.0000068822.10113.9E
   PubMed Web of Science ®Google Scholar
• Walker EMK, Bell M, Cook TM, et al. Patient reported outcome of adult perioperative anaesthesia in the United Kingdom: a cross-sectional observational study. Br J Anaesth. 2016;117(6):758–766. doi:10.1093/bja/aew381
   PubMed Web of Science ®Google Scholar
• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013;118(4):934–944. doi:10.1097/ALN.0b013e31828866b3
   PubMed Web of Science ®Google Scholar
• Svensson I, Sjöström B, Haljamäe H. Influence of expectations and actual pain experiences on satisfaction with postoperative pain management. Eur J Pain. 2001;5(2):125–133. doi:10.1053/eujp.2001.0227
   PubMed Web of Science ®Google Scholar
• Thienthong S, Niruthisard S, Ittichaikulthon W, et al. Clinical guidance for acute postoperative pain management 2019 The Royal College of Anesthesiologists of Thailand (RCAT) and The Thai Association for Study of Pain (TASP). Thai J Anesthesiol. 2020;46(1):47–70.
   Google Scholar
• Mwaka G, Thikra S, Mung’ayi V. The prevalence of postoperative pain in the first 48 hours following day surgery at a tertiary hospital in Nairobi. Afr Health Sci. 2013;13(3):768–776. doi:10.4314/ahs.v13i3.36
   PubMed Web of Science ®Google Scholar
• Gandhi K, Heitz JW, Viscusi ER. Challenges in acute pain management. Anesthesiol Clin. 2011;29(2):291–309. doi:10.1016/j.anclin.2011.04.009
   PubMedGoogle Scholar
• Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005;23(1):21–36. doi:10.1016/j.atc.2004.11.013
   PubMedGoogle Scholar
• Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017;10:2287–2298. doi:10.2147/JPR.S144066
   PubMed Web of Science ®Google Scholar
• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006;367(9522):1618–1625. doi:10.1016/S0140-6736(06)68700-X
   PubMed Web of Science ®Google Scholar
• Stein C. Opioid Receptors. Annu Rev Med. 2016;67(433–451):433–451. doi:10.1146/annurev-med-062613-093100
   PubMedGoogle Scholar
• Tan HS, Habib AS. Oliceridine: a novel drug for the management of moderate to severe acute pain - a review of current evidence. J Pain Res. 2021;14:969–979. doi:10.2147/JPR.S278279
   PubMed Web of Science ®Google Scholar
• Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015;95(2):301–318. doi:10.1016/j.suc.2014.10.002
   PubMed Web of Science ®Google Scholar
• Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013;26(3):191–196. doi:10.1055/s-0033-1351138
   PubMed Web of Science ®Google Scholar
• Shafi S, Collinsworth AW, Copeland LA, et al. Association of opioid-related adverse drug events with clinical and cost outcomes among surgical patients in a large integrated health care delivery system. JAMA Surg. 2018;153(8):757–763. doi:10.1001/jamasurg.2018.1039
   PubMed Web of Science ®Google Scholar
• Khanna AK, Bergese SD, Jungquist CR, et al. Prediction of opioid-induced respiratory depression on inpatient wards using continuous capnography and oximetry: an international prospective, observational trial. Anesth Analg. 2020;131(4):1012–1024. doi:10.1213/ANE.0000000000004788
   PubMed Web of Science ®Google Scholar
• Small C, Laycock H. Acute postoperative pain management. Br J Surg. 2020;107(2):e70–e80. doi:10.1002/bjs.11477
   PubMed Web of Science ®Google Scholar
• Callinan CE, Neuman MD, Lacy KE, Gabison C, Ashburn MA. The initiation of chronic opioids: a survey of chronic pain patients. J Pain. 2017;18(4):360–365. doi:10.1016/j.jpain.2016.11.001
   PubMed Web of Science ®Google Scholar
• Wide-ranging online data for epidemiologic research (WONDER). Atlanta. GA: CDC, National Center for Health Statistics; 2021. Available from http://wonder.cdc.gov. Accessed March 13, 2023.
   Google Scholar
• Luo F, Li M, Florence C. State-level economic costs of opioid use disorder and fatal opioid overdose - United States, 2017. MMWR Morb Mortal Wkly Rep. 2021;70(15):541–546. doi:10.15585/mmwr.mm7015a1
   PubMed Web of Science ®Google Scholar
• Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048–1056. doi:10.1213/00000539-199311000-00030
   PubMed Web of Science ®Google Scholar
• Maund E, McDaid C, Rice S, Wright K, Jenkins B, Woolacott N. Paracetamol and selective and non-selective non-steroidal anti-inflammatory drugs for the reduction in morphine-related side-effects after major surgery: a systematic review. Br J Anaesth. 2011;106(3):292–297. doi:10.1093/bja/aeq406
   PubMed Web of Science ®Google Scholar
• Gan TJ, Epstein RS, Leone-Perkins ML, Salimi T, Iqbal SU, Whang PG. Practice patterns and treatment challenges in acute postoperative pain management: a survey of practicing physicians. Pain Ther. 2018;7(2):205–216. doi:10.1007/s40122-018-0106-9
   PubMed Web of Science ®Google Scholar
• Azzam AAH, Lambert DG. Preclinical discovery and development of oliceridine (Olinvyk®) for the treatment of post-operative pain. Expert Opin Drug Discov. 2022;17(3):215–223. doi:10.1080/17460441.2022.2008903
   PubMed Web of Science ®Google Scholar
• Gan TJ, Wase L. Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain. Drugs Today. 2020;56(4):269–286. doi:10.1358/dot.2020.56.4.3107707
   PubMed Web of Science ®Google Scholar
• Bohn LM, Lefkowitz RJ, Gainetdinov RR, Peppel K, Caron MG, Lin FT. Enhanced morphine analgesia in mice lacking beta-arrestin 2. Science. 1999;286(5449):2495–2498. doi:10.1126/science.286.5449.2495
   PubMed Web of Science ®Google Scholar
• Raehal KM, Walker JK, Bohn LM. Morphine side effects in beta-arrestin 2 knockout mice. J Pharmacol Exp Ther. 2005;314(3):1195–1201. doi:10.1124/jpet.105.087254
   PubMed Web of Science ®Google Scholar
• Chen XT, Pitis P, Liu G, et al. Structure-activity relationships and discovery of a G protein biased μ opioid receptor ligand, [(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro-[4.5]decan-9-yl]ethyl})amine (TRV130), for the treatment of acute severe pain. J Med Chem. 2013;56(20):8019–8031. doi:10.1021/jm4010829
   PubMed Web of Science ®Google Scholar
• DeWire SM, Yamashita DS, Rominger DH, et al. A G protein-biased ligand at the μ-opioid receptor is potently analgesic with reduced gastrointestinal and respiratory dysfunction compared with morphine. J Pharmacol Exp Ther. 2013;344(3):708–717. doi:10.1124/jpet.112.201616
   PubMed Web of Science ®Google Scholar
• Liang DY, Li WW, Nwaneshiudu C, Irvine KA, Clark JD. Pharmacological characters of oliceridine, a μ-opioid receptor G-protein-biased ligand in mice. Anesth Analg. 2019;129(5):1414–1421. doi:10.1213/ANE.0000000000003662
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Oliceridine briefing document: FDA advisory committee meeting; 2018. Available from: https://www.fda.gov/media/121230/download. Accessed October 23, 2022.
   Google Scholar
• Altarifi AA, David B, Muchhala KH, Blough BE, Akbarali H, Negus SS. Effects of acute and repeated treatment with the biased mu opioid receptor agonist TRV130 (oliceridine) on measures of antinociception, gastrointestinal function, and abuse liability in rodents. J Psychopharmacol. 2017;31(6):730–739. doi:10.1177/0269881116689257
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). Highlights of prescribing information - olinvyk (oliceridine); 2021. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210730s001lbl.pdf. Accessed October 1, 2022.
   Google Scholar
• Nafziger AN, Arscott KA, Cochrane K, Skobieranda F, Burt DA, Fossler MJ. The influence of renal or hepatic impairment on the pharmacokinetics, safety, and tolerability of oliceridine. Clin Pharmacol Drug Dev. 2020;9(5):639–650. doi:10.1002/cpdd.750
   PubMed Web of Science ®Google Scholar
• Soergel DG, Subach RA, Burnham N, et al. Biased agonism of the μ-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014;155(9):1829–1835. doi:10.1016/j.pain.2014.06.011
   PubMed Web of Science ®Google Scholar
• Soergel DG, Subach RA, Sadler B, et al. First clinical experience with TRV130: pharmacokinetics and pharmacodynamics in healthy volunteers. J Clin Pharmacol. 2014;54(3):351–357. doi:10.1002/jcph.207
   PubMed Web of Science ®Google Scholar
• Viscusi ER, Webster L, Kuss M, et al. A randomized, Phase 2 study investigating TRV130, a biased ligand of the μ-opioid receptor, for the intravenous treatment of acute pain. Pain. 2016;157(1):264–272. doi:10.1097/j.pain.0000000000000363
   PubMed Web of Science ®Google Scholar
• Singla N, Minkowitz HS, Soergel DG, et al. A randomized, Phase IIb study investigating oliceridine (TRV130), a novel µ-receptor G-protein pathway selective (μ-GPS) modulator, for the management of moderate to severe acute pain following abdominoplasty. J Pain Res. 2017;10:2413–2424. doi:10.2147/JPR.S137952
   PubMed Web of Science ®Google Scholar
• McNicol ED, Ferguson MC, Hudcova J. Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain. Cochrane Database Syst Rev. 2015;2015(6):CD003348. doi:10.1002/14651858.CD003348.pub3
   PubMedGoogle Scholar
• Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. 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. J Pain Res. 2019;12:927–943. doi:10.2147/JPR.S171013
   PubMed Web of Science ®Google Scholar
• Singla NK, Skobieranda F, Soergel DG, et al. 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. Pain Pract. 2019;19(7):715–731. doi:10.1111/papr.12801
   PubMed Web of Science ®Google Scholar
• Bergese SD, Brzezinski M, Hammer GB, et al. 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. J Pain Res. 2019;12:3113–3126. doi:10.2147/JPR.S217563
   PubMed Web of Science ®Google Scholar
• Beard TL, Michalsky C, Candiotti KA, et al. Oliceridine is associated with reduced risk of vomiting and need for rescue antiemetics compared to morphine: exploratory analysis from two phase 3 randomized placebo and active controlled trials. Pain Ther. 2021;10(1):401–413. doi:10.1007/s40122-020-00216-x
   PubMed Web of Science ®Google Scholar
• Ayad S, Demitrack MA, Burt DA, et al. Evaluating the incidence of opioid-induced respiratory depression associated with oliceridine and morphine as measured by the frequency and average cumulative duration of dosing interruption in patients treated for acute postoperative pain. Clin Drug Investig. 2020;40(8):755–764. doi:10.1007/s40261-020-00936-0
   PubMed Web of Science ®Google Scholar
• Dahan A, van Dam CJ, Niesters M, et al. Benefit and risk evaluation of biased μ-receptor agonist oliceridine versus morphine. Anesthesiology. 2020;133(3):559–568. doi:10.1097/ALN.0000000000003441
   PubMed Web of Science ®Google Scholar
• Bergese S, Berkowitz R, Rider P, et al. Low incidence of postoperative respiratory depression with oliceridine compared to morphine: a retrospective chart analysis. Pain Res Manag. 2020;2020:7492865. doi:10.1155/2020/7492865
   PubMed Web of Science ®Google Scholar
• Brzezinski M, Hammer GB, Candiotti KA, et al. Low incidence of opioid-induced respiratory depression observed with oliceridine regardless of age or body mass index: exploratory analysis from a phase 3 open-label trial in postsurgical pain. Pain Ther. 2021;10(1):457–473. doi:10.1007/s40122-020-00232-x
   PubMed Web of Science ®Google Scholar
• Simons P, van der Schrier R, van Lemmen M, et al. Respiratory effects of biased-ligand oliceridine in older volunteers: a pharmacokinetic-pharmacodynamic comparison with morphine. Anesthesiology. 2022. doi:10.1097/ALN.0000000000004473
   Web of Science ®Google Scholar
• Simpson KN, Fossler MJ, Wase L, Demitrack MA. Cost-effectiveness and cost-benefit analysis of oliceridine in the treatment of acute pain. J Comp Eff Res. 2021;10(15):1107–1119. doi:10.2217/cer-2021-0107
   PubMed Web of Science ®Google Scholar
• Simpson KN, Fossler MJ, Wase L, Demitrack MA, Wandstrat TL. Budget impact and pharmacy costs with targeted use of oliceridine for postsurgical pain in patients at high risk of opioid-related adverse events. Expert Rev Pharmacoecon Outcomes Res. 2022;22(4):671–681. doi:10.1080/14737167.2022.2038137
   PubMed Web of Science ®Google Scholar