Buprenorphine/naloxone sublingual tablet (Zubsolv®): a guide to its use in the maintenance treatment of opioid dependence in the USA

Abstract

Zubsolv® is a new sublingual formulation of buprenorphine/naloxone that is indicated for the maintenance treatment of opioid dependence in the USA. The effectiveness and tolerability of buprenorphine/naloxone in this indication is well established. Relative to other sublingual formulations of buprenorphine/naloxone, Zubsolv® dissolves more rapidly, has greater bioavailability, tastes better, and may be preferred by many patients.

This is a preview of subscription content, access via your institution.

References

  1. 1.

    Colson J, Helm S, Silverman SM. Office-based opioid dependence treatment. Pain Physician. 2012;15(3 Suppl):ES231–6.

    Google Scholar 

  2. 2.

    Holmes D. Prescription drug addiction: the treatment challenge. Lancet. 2012;379(9810):17–8.

    PubMed  Article  Google Scholar 

  3. 3.

    Kraus ML, Alford DP, Kotz MM, et al. Statement of the American Society of Addiction Medicine Consensus Panel on the use of buprenorphine in office-based treatment of opioid addiction. J Addict Med. 2011;5(4):254–63.

    PubMed  Article  CAS  Google Scholar 

  4. 4.

    Nicholls L, Bragaw L, Ruetsch C. Opioid dependence treatment and guidelines. J Manag Care Pharm. 2010;16(1 Suppl B):S14–21.

    Google Scholar 

  5. 5.

    Robinson SE. Buprenorphine-containing treatments: place in the management of opioid addiction. CNS Drugs. 2006;20(9):697–712.

    PubMed  Article  CAS  Google Scholar 

  6. 6.

    Mattick RP, Breen C, Kimber J, et al. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2009;(3):CD002209.

  7. 7.

    Mattick RP, Kimber J, Breen C, et al. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2008(2):CD002207.

  8. 8.

    Mégarbane B, Hreiche R, Pirnay S, et al. Does high-dose buprenorphine cause respiratory depression? Possible mechanisms and therapeutic consequences. Toxicol Rev. 2006;25(2):79–85.

    PubMed  Article  Google Scholar 

  9. 9.

    Jasinski DR, Pevnick JS, Griffith JD. Human pharmacology and abuse potential of the analgesic buprenorphine: a potential agent for treating narcotic addiction. Arch Gen Psychiatry. 1978;35(4):501–16.

    PubMed  Article  CAS  Google Scholar 

  10. 10.

    Bickel WK, Stitzer ML, Bigelow GE, et al. Buprenorphine: dose-related blockade of opioid challenge effects in opioid dependent humans. J Pharmacol Exp Ther. 1988;247(1):47–53.

    PubMed  CAS  Google Scholar 

  11. 11.

    Walsh SL, June HL, Schuh KJ, et al. Effects of buprenorphine and methadone in methadone-maintained subjects. Psychopharmacology (Berl). 1995;119(3):268–76.

    PubMed  Article  CAS  Google Scholar 

  12. 12.

    Wesson DR. Buprenorphine in the treatment of opiate dependence: its pharmacology and social context of use in the U.S. J Psychoactive Drugs. 2004;Suppl. 2:119–28.

  13. 13.

    Walsh SL, Preston KL, Stitzer ML, et al. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994;55(5):569–80.

    PubMed  Article  CAS  Google Scholar 

  14. 14.

    Ciraulo DA, Hitzemann RJ, Somoza E, et al. Pharmacokinetics and pharmacodynamics of multiple sublingual buprenorphine tablets in dose-escalation trials. J Clin Pharmacol. 2006;46:179–92.

    PubMed  Article  CAS  Google Scholar 

  15. 15.

    Fiellin DA, Friedland GH, Gourevitch MN. Opioid dependence: rationale for and efficacy of existing and new treatments. Clin Infect Dis. 2006;43(Suppl 4):S173–7.

    Google Scholar 

  16. 16.

    Naloxone hydrochloride injection: US prescribing information. Lake Forest (IL): Hospira, Inc. 2007.

  17. 17.

    Zubsolv® (buprenorphine and naloxone sublingual tablets) for sublingual administration (CIII): US prescribing information. New York: Orexo US, Inc. 2013.

  18. 18.

    Donaher PA, Welsh C. Managing opioid addiction with buprenorphine. Am Fam Physician. 2006;73(9):1573–8.

    PubMed  Google Scholar 

  19. 19.

    Jönsson M, Fischer A, Tiberg C, et al. A novel buprenorphine/naloxone tablet formulation for the treatment of opioid dependence [poster]. In: 44th Annual Medical-Scientific Conference of the American Society of Addiction Medicine; 25–28 Apr 2013; Chicago.

  20. 20.

    Ling W, Hillhouse M, Domier C, et al. Buprenorphine tapering schedule and illicit opioid use. Addiction. 2009;104(2):256–65.

    PubMed  Article  Google Scholar 

  21. 21.

    Orman JS, Keating GM. Buprenorphine/naloxone: a review of its use in the treatment of opioid dependence. Drugs. 2009;69(5):577–607.

    PubMed  Article  CAS  Google Scholar 

  22. 22.

    Ling W, Jacobs P, Hillhouse M, et al. From research to the real world: buprenorphine in the decade of the Clinical Trials Network. J Subst Abuse Treat. 2010;38(Suppl 1):S53–60.

    PubMed  Article  Google Scholar 

  23. 23.

    Orexo. Orexo takes large step forward on the road to improve treatment for people dependent on opioid pain killers [media release]. 2012 Jul 2 [online]. Available from: http://www.orexo.com/en/Investor-Relations/Press-releases/?guid=680249.

  24. 24.

    Fudala PJ, Bridge TP, Herbert S, et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003;349(10):949–58.

    PubMed  Article  CAS  Google Scholar 

  25. 25.

    Kamien JB, Branstetter SA, Amass LA. Buprenorphine-naloxone versus methadone maintenance therapy: a randomised double-blind trial with opioid dependent patients. Heroin Addict Relat Clin Probl. 2008;10(4):5–18.

    Google Scholar 

  26. 26.

    Kakko J, Grönbladh L, Svanborg KD, et al. A stepped care strategy using buprenorphine and methadone versus conventional methadone maintenance in heroin dependence: a randomized controlled trial. Am J Psychiatry. 2007;164(5):797–803.

    PubMed  Article  Google Scholar 

  27. 27.

    Apelt SM, Scherbaum N, Gölz J, et al. Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care. Pharmacopsychiatry. 2013;46(3):94–107.

    PubMed  Article  CAS  Google Scholar 

  28. 28.

    Stimolo C, Favero VD, Zecchinato G, et al. Safety and tolerability of the switch from buprenorphine to buprenorphine/naloxone in an Italian addiction treatment centre. Clin Drug Investig. 2010;30(Suppl 1):27–31.

    PubMed  Article  CAS  Google Scholar 

Download references

Acknowledgement

The manuscript was reviewed by: S. Helm, Pacific Coast Pain Management Center, Laguna Hills, CA, USA; M. Hillhouse, UCLA Integrated Substance Abuse Programs, Los Angeles, CA, USA, C.M. Renzelli, Gateway Rehabilitation Center, Moon Township, PA, USA.

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Katherine A. Lyseng-Williamson.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Lyseng-Williamson, K.A. Buprenorphine/naloxone sublingual tablet (Zubsolv®): a guide to its use in the maintenance treatment of opioid dependence in the USA. Drugs Ther Perspect 29, 336–341 (2013). https://doi.org/10.1007/s40267-013-0079-z

Download citation

Keywords

  • Naloxone
  • Buprenorphine
  • Atazanavir
  • Opioid Dependence
  • Opioid Withdrawal