268
Views
8
CrossRef citations to date
0
Altmetric
Drug evaluation

An up-to-date overview of sublingual sufentanil for the treatment of moderate to severe pain

, ORCID Icon &
Pages 1407-1418 | Received 04 Feb 2020, Accepted 04 May 2020, Published online: 03 Jun 2020

References

  • Correll DJ , Vlassakov KV , Kissin I. No evidence of real progress in treatment of acute pain, 1993–2012: scientometric analysis. J Pain Res. 2014;7:199–210.
  • Kuusniemi K , Pöyhiä R . Present-day challenges and future solutions in postoperative pain management: results from PainForum 2014. J Pain Res. 2016;9:25–36.
  • Kinnunen M , Piirainen P , Kokki H , et al. Updated clinical pharmacokinetics and pharmacodynamics of oxycodone. Clin Pharmacokinet. 2019;58:705–725.
  • Emmerson PJ , Liu MR , Woods JH , et al. Binding affinity and selectivity of opioids at mu, delta and kappa receptors in monkey brain membranes. J Pharmacol Exp Ther. 1994;271(3):1630–1637.
  • Niemegeers CJ , Schellekens KH , Van Bever WF , et al. Sufentanil, a very potent and extremely safe intravenous morphine-like compound in mice, rats and dogs. Arzneimittelforschung. 1976;26(8):1551–1556.
  • Sinatra RS , Sevarino FB , Paige D . Patient-controlled analgesia with sufentanil: a comparison of two different methods of administration. J Clin Anesth. 1996;8(2):123–129.
  • Henderson JM , Brodsky DA , Fisher DM , et al. Pre-induction of anesthesia in pediatric patients with nasally administered sufentanil. Anesthesiology. 1988;68(5):671–675. .
  • Vercauteren M , Boeckx E , Hanegreefs G , et al. Intranasal sufentanil for pre-operative sedation. Anaesthesia. 1988;43(4):270–273. .
  • Zalviso . European medicine agency assessment report. European Medicine Agency; 2015; [cited 2019 Dec 15 ]. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/zalviso.
  • AcelRx pharmaceuticals submits new drug application to the FDA for Zalviso [internet]. Drugs.com; 2013; [cited 2020 Jan 20 ]. Available at: https://www.drugs.com/nda/zalviso_130930.html
  • Dzuveo . European medicine agency assessment report. European Medicine Agency; 2018; [cited 2020 Jan 20 ]. Available at: https://www.ema.europa.eu/en/documents/assessment-report/dzuveo-epar-public-assessment-report_en.pdf.
  • FDA advisory committee recommends approval of dsuvia for the treatment of moderate-to-severe acute pain. [Internet]. Drugs.com; 2018; [cited 2020 Jan 20 ]. Available at: https://www.drugs.com/nda/dsuvia_181012.html.
  • Dzuveo: summary of product characteristics. European Medicine Agency; 2018; [cited 2020 Jan 20 ]. Available at: https://www.ema.europa.eu/en/documents/product-information/dzuveo-epar-product-information_en.pdf
  • Drug approval package: Dsuvia. Center for Drug Evaluation and Research; 2018; [cited 2020 Jan 20 ]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209128Orig1s000Lbl.pdf
  • Porela-Tiihonen S , Kokki M , Kokki H . Sufentanil sublingual formulation for the treatment of acute, moderate to severe postoperative pain in adult patients. Expert Rev Neurother. 2017;17(2):101–111.
  • Zhu J , Xue J-C , Law P-Y , et al. The region in the μ opioid receptor conferring selectivity for sufentanil over the δ receptor is different from that over the κ receptor. FEBS Lett. 1996;384(2):198–202.
  • Volpe DA , Tobin GAM , Mellon RD , et al. Uniform assessment and ranking of opioid Mu receptor binding constants for selected opioid drugs. Regul Toxicol Pharmacol. 2011;59(3):385–390.
  • Melson TI , Boyer DL , Minkowitz HS , et al., Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 14(8): 679–688. 2014.
  • Flacke JW , Bloor BC , Kripke BJ , et al. Comparison of morphine, meperidine, fentanyl, and sufentanil in balanced anesthesia: a double-blind study. Anesth Analg. 1985;64(9):897–910.
  • Kokki H , Ruuskanen A , Karvinen M . Comparison of epidural pain treatment with sufentanil-ropivacaine infusion with and without epinephrine in children. Acta Anaesthesiol Scand. 2002;46(6):647–653.
  • Dubois-Primo J , Dewachter B , Massaut J . Analgesic anesthesia with fentanyl (F) and sufentanil (SF) in coronary surgery. A double blind study. Acta Anaesthesiol Belg. 1979;30(2):113–126.
  • Sufentanil . [Internet]. Drugbank.ca 2005. [cited 2020 Jan 20 ] Available from: https://www.drugbank.ca/drugs/DB00708
  • Lahtinen P , Kokki H , Hynynen M . Pain after cardiac surgery: a prospective cohort study of one-year incidence and intensity. Anesthesiology. 2006;105(4):794–800.
  • Kokki H , Tuovinen K , Hendolin H . The effect of intravenous ketoprofen on postoperative epidural sufentanil analgesia in children. Anesth Analg. 1999;88(5):1036–1041.
  • Väänänen A , Kuukasjärvi M , Tekay A , et al. Spinal and epidural sufentanil and fentanyl in early labour. Acta Anaesthesiol Scand. 2019;63(10):1413–1418.
  • Willsie SK , Evashenk MA , Hamel LG , et al. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015;37(1):145–155. .
  • Fisher DM , Chang P , Wada DR , et al. Pharmacokinetic properties of a sufentanil sublingual tablet intended to treat acute pain. Anesthesiology. 128(5): 943–952. 2018.
  • Lehmann KA , Gerhard A , Horrichs-Haermeyer G , et al. Postoperative patient-controlled analgesia with sufentanil: analgesic efficacy and minimum effective concentrations. Acta Anaesthesiol Scand. 1991;35(3):221–226.
  • Wilde M , Pichini S , Pacifici R , et al. Metabolic pathways and potencies of new fentanyl analogs. Front Pharmacol. 2019;10:238.
  • Minkowitz HS , Singla NK , Evashenk MA , et al. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain. Reg Anesth Pain Med. 2013;38(2):131–139.
  • Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s): sufentanil. European Medicines Agency; 2019; [cited 2020 Jan 20 ] Available from: https://www.ema.europa.eu/documents/scientific-conclusion/zalviso-h-c-psusa-00002798-201811-epar-scientific-conclusions-grounds-variation-terms-marketing_en.pdf
  • Pu J , Wang N , Huang Z-K , et al. Correlation between gene polymorphism and opioid efficacy in patients with gastric or intestinal cancer. Eur Rev Med Pharmacol Sci. 2019;23(21):9393–9410.
  • Zhang H , Chen M , Wang X , et al. Patients with CYP3A4*1G genetic polymorphism consumed significantly lower amount of sufentanil in general anesthesia during lung resection. Medicine (Baltimore). 2017;96(4):e6013.
  • Lv J , Liu F , Feng N , et al. CYP3A4 gene polymorphism is correlated with individual consumption of sufentanil. Acta Anaesthesiol Scand. 2018;62(10):1367–1373.
  • Babazade R , Turan A . Pharmacokinetic and pharmacodynamic evaluation of sublingual sufentanil in the treatment of post-operative pain. Expert Opin Drug Metab Toxicol. 2016;12(2):217–224.
  • Minkowitz HS , Leiman D , Melson T , et al. Sufentanil sublingual tablet 30 mcg for the management of pain following abdominal surgery: a randomized, placebo-controlled, Phase-3 study. Pain Pract. 17(7): 848–858. 2017.
  • DSUVIA ™ (sufentanil) sublingual tablet, 30 mcg AcelRx briefing document FDA advisory committee meeting. [cited 2020 Jan 20 ]; Available at: https://www.fda.gov/media/118092/download
  • Pogatzki-Zahn E , Kranke P , Winner J , et al. Real-world use of the sufentanil sublingual tablet system for patient-controlled management of acute postoperative pain: a prospective noninterventional study. Curr Med Res Opin. 2019;30:1–8.
  • Fabio C , Giuseppe P , Chiara P , et al. Sufentanil sublingual tablet system (Zalviso®) as an effective analgesic option after thoracic surgery: an observational study. Saudi J Anaesth. 2019;13(3):222–226.
  • Kokki M , Välitalo P , Rasanen I , et al. Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy. Eur J Clin Pharmacol. 2012;68(10):1357–1363.
  • Hutchins JL , Leiman D , Minkowitz HS , et al. An open-label study of sufentanil sublingual tablet 30 Mcg in patients with postoperative pain. Pain Med. 19(10): 2058–2068. 2018.
  • Ljungqvist O , Scott M , Fearon KC . Enhanced recovery after surgery: a review. JAMA Surg. 2017;152(3):292–298.
  • Turi S , Deni F , Lombardi G , et al. Sufentanil Sublingual Tablet System (SSTS) for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol: an observational study. J Pain Res. 2019;12:2313–2319.
  • Härkänen L , Kokki M , Huopio J , et al. Buprenorphine for pain management in osteoarthritis patients scheduled for arthroplasty - a randomized, double-blind, placebo controlled trial. Austin J Anesthesia Analgesia. 2018;6:1065.
  • Kostamovaara PA , Hendolin H , Kokki H , et al. Ketorolac, diclofenac and ketoprofen are equally efficacious for pain relief after total hip replacement surgery. Br J Anaesth. 1998;81(3):369–372.
  • Piirainen A , Kokki M , Hautajärvi H , et al. The cerebrospinal fluid distribution of postoperatively administred dexketoprofen and etoricoxib and their effect on pain and inflammatory markers in patients undergoing hip arthroplasty. Clin Drug Investig. 2016;36(7):545–555.
  • van Veen DE , Verhelst CC , van Dellen RT , et al. Sublingual sufentanil (Zalviso) patient-controlled analgesia after total knee arthroplasty: a retrospective comparison with oxycodone with or without dexamethasone. J Pain Res. 2018;11:3205–3210.
  • Meijer F , Cornelissen P , Sie C , et al. Sublingual sufentanil for postoperative pain relief: first clinical experiences. J Pain Res. 2018;11:987–992.
  • Miner JR , Rafique Z , Minkowitz HS , et al. Sufentanil sublingual tablet 30 mcg for moderate-to-severe acute pain in the ED. Am J Emerg Med. 36(6): 954–961. 2018.
  • Callahan CM , Unverzagt FW , Hui SL , et al. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002;40(9):771–781.
  • Miner JR , Melson TI , Leiman D , et al. Pooled Phase III safety analysis of sufentanil sublingual tablets for short-term treatment of moderate-to-severe acute pain. Pain Manag. 9(3): 259–271. 2019.
  • Räisänen S , Kokki M , Kokki H , et al. The use of epidural analgesia for intrapartum pain relief in publicly funded healthcare. Acta Anaesthesiol Scand. 2014;58(3):291–297.
  • Kokki M , Heikkinen AT , Raatikainen K , et al. Pharmacokinetics of intranasal fentanyl in parturient. Br J Anaesth. 115(4): 635–636. 2015.
  • Chouchou F , Khoury S , Chauny J-M , et al. Postoperative sleep disruptions: a potential catalyst of acute pain? Sleep Med Rev. 2014;18(3):273–282.
  • Lindell-Osuagwu L , Hakkarainen M , Sepponen K , et al. Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the European Union paediatric regulation. J Clin Pharm Ther. 39(2): 144–153. 2014.
  • Kokki H , Rasanen I , Laisalmi M , et al. Comparison of oxycodone pharmacokinetics after buccal and sublingual administration in children. Clin Pharmacokinet. 45(7): 745–754. 2006.
  • Wick EC , Grant MC , Wu CL . Postoperative multimodal analgesia pain management with nonopioid analgesics and techniques: a review. JAMA Surg. 2017;152(7):691–697.
  • Devulder J . Hyperalgesia induced by high-dose intrathecal sufentanil in neuropathic pain. J Neurosurg Anesthesiol. 1997;9(2):146–148.
  • Mistry R , Mbanya Z , Liedgens H . Cost-effectiveness of the sufentanil sublingual tablet system Vs. IV PCA morphine for the treatment of acute moderate to severe post-operative pain in Ireland. Value Health. 2017;20(9):A582–A583.
  • Kagel EM , Rayan GM . Intravenous catheter complications in the hand and forearm. J Trauma. 2004;56(1):123–127.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.