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Capsaicin 8% dermal patch in peripheral neuropathic pain: a profile of its use

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Abstract

A dermal patch containing a high (8%) capsaicin concentration (hereafter referred to as the capsaicin 8% dermal patch) [Qutenza®] is a useful option for the treatment of peripheral neuropathic pain (PNP). The patch, referred to as Qutenza 179 mg cutaneous patch in the EU summary of product characteristics, is indicated in the EU for the treatment of PNP in adults, either alone or in combination with other medicinal products for pain. Prolonged exposure to capsaicin (the main pungent component in hot chilli peppers) appears to engender analgesia/pain relief by inducing cutaneous nociceptor ‘defunctionalisation’ [i.e. a cascade of events, including a reduction in TRPV1 (transient receptor potential vanilloid-1) receptor sensitivity to various painful or noxious stimuli, resulting in impaired local nociceptor function for an extended period]. Across clinical and real-world studies in patients with painful diabetic peripheral neuropathy (PDPN) or non-diabetic PNP, including post-herpetic neuralgia (PHN) and HIV-associated neuropathy, single applications of the capsaicin 8% dermal patch generally relieved pain and improved health-related quality of life, patient status and/or treatment satisfaction. Pain relief was at least sustained following repeated applications for ≤ 52 weeks. As the capsaicin 8% dermal patch is associated with minimal systemic absorption, its use is expected to result in few systemic adverse events or drug–drug interactions.

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References

  1. International Association for the Study of Pain. IASP terminology. 2017. https://www.iasp-pain.org/terminology. Accessed 18 Nov 2019.

  2. Scholz J, Finnerup NB, Attal N, et al. The IASP classification of chronic pain for ICD-11: chronic neuropathic pain. Pain. 2019;160(1):53–9.

    Article  Google Scholar 

  3. Zilliox LA. Neuropathic pain. Continuum. 2017;23(2):512–32.

    PubMed  Google Scholar 

  4. National Institute for Health and Care Excellence. Neuropathic pain: pharmacological management: the pharmacological management of neuropathic pain in adults in non-specialist settings (NICE clinical guideline 173). 2017. http://www.nice.org.uk/guidance/cg173. Accessed 30 Oct 2019.

  5. Pickering G, Martin E, Tiberghien F, et al. Localized neuropathic pain: an expert consensus on local treatments. Drug Des Devel Ther. 2017;11:2709–18.

    Article  CAS  Google Scholar 

  6. Baranidharan G, Das S, Bhaskar A. A review of the high-concentration capsaicin patch and experience in its use in the management of neuropathic pain. Ther Adv Neurol Disord. 2013;6(5):287–97.

    Article  Google Scholar 

  7. European Medicines Agency. Qutenza (capsaicin): EU assessment report. 2015. https://www.ema.europa.eu/. Accessed 30 Oct 2019.

  8. Anand P, Bley K. Topical capsaicin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. Br J Anaesth. 2011;107(4):490–502.

    Article  CAS  Google Scholar 

  9. Blair HA. Capsaicin 8% dermal patch: a review in peripheral neuropathic pain. Drugs. 2018;78(14):1489–500.

    Article  CAS  Google Scholar 

  10. Grünenthal GmbH. Qutenza 179 mg cutaneous patch: EU summary of product characteristics. 2019. http://www.ema.europa.eu/. Accessed 30 Oct 2019.

  11. Leppert W, Malec-Milewska M, Zajaczkowska R, et al. Transdermal and topical drug administration in the treatment of pain. Molecules. 2018;23(3):1–17.

    Article  Google Scholar 

  12. Frias B, Merighi A. Capsaicin, nociception and pain. Molecules. 2016. https://doi.org/10.3390/molecules21060797.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Pereira MP, Luling H, Dieckhofer A, et al. Application of an 8% capsaicin patch normalizes epidermal TRPV1 expression but not the decreased intraepidermal nerve fibre density in patients with brachioradial pruritus. J Eur Acad Dermatol Venereol. 2018;32(9):1535–41.

    Article  CAS  Google Scholar 

  14. Kennedy WR, Vanhove GF, Lu S-P, et al. A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers. J Pain. 2010;11(6):579–87.

    Article  CAS  Google Scholar 

  15. Simpson DM, Robinson-Papp J, Van J, et al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J Pain. 2017;18(1):42–53.

    Article  CAS  Google Scholar 

  16. Vinik AI, Perrot S, Vinik EJ, et al. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol. 2016;16(251):1–14.

    Google Scholar 

  17. Backonja M, Wallace MS, Blonsky ER, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008;7(12):1106–12.

    Article  CAS  Google Scholar 

  18. Irving GA, Backonja MM, Dunteman E, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med. 2011;12:99–109.

    Article  Google Scholar 

  19. Simpson DM, Brown S, Tobias J. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008;70(24):2305–13.

    Article  CAS  Google Scholar 

  20. Clifford DB, Simpson DM, Brown S, et al. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr. 2012;59(2):126–33.

    Article  CAS  Google Scholar 

  21. Haanpaa M, Cruccu G, Nurmikko TJ, et al. Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain. Eur J Pain. 2016;20(2):316–28.

    Article  CAS  Google Scholar 

  22. Perrot S, Ortega E, Vinik EJ, et al. Efficacy, quality of life and treatment satisfaction with capsaicin 8% patch versus standard of care in painful diabetic peripheral neuropathy [abstract no. 1067]. Diabetologia. 2015;58(Suppl. 1):S514.

  23. Brown S, Simpson DM, Moyle G, et al. NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials. AIDS Res Ther. 2013;10(1):5.

    Article  CAS  Google Scholar 

  24. Cruccu G, Nurmikko TJ, Ernault E, et al. Superiority of capsaicin 8% patch versus oral pregabalin on dynamic mechanical allodynia in patients with peripheral neuropathic pain. Eur J Pain. 2018;22(4):700–6.

    Article  CAS  Google Scholar 

  25. Backonja MM, Malan TP, Vanhove GF. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension. Pain Med. 2010;11:600–8.

    Article  Google Scholar 

  26. Simpson DM, Gazda S, Brown S, et al. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manag. 2010;39(6):1053–64.

    Article  CAS  Google Scholar 

  27. Simpson DM, Brown S, Tobias JK, et al. NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study. Clin J Pain. 2014;30(2):134–42.

    PubMed  Google Scholar 

  28. Lanteri-Minet M, Perrot S. QAPSA: post-marketing surveillance of capsaicin 8% patch for long-term use in patients with peripheral neuropathic pain in France. Curr Med Res Opin. 2019;35(3):417–26.

    Article  CAS  Google Scholar 

  29. Maihofner C, Heskamp ML. Prospective, non-interventional study on the tolerability and analgesic effectiveness over 12 weeks after a single application of capsaicin 8% cutaneous patch in 1044 patients with peripheral neuropathic pain: first results of the QUEPP study. Curr Med Res Opin. 2013;29(6):673–83.

    Article  CAS  Google Scholar 

  30. Maihofner CG, Heskamp ML. Treatment of peripheral neuropathic pain by topical capsaicin: impact of pre-existing pain in the QUEPP-study. Eur J Pain. 2014;18(5):671–9.

    Article  CAS  Google Scholar 

  31. Hansson P, Jensen TS, Kvarstein G, et al. Pain-relieving effectiveness, quality of life and tolerability of repeated capsaicin 8% patch treatment of peripheral neuropathic pain in Scandinavian clinical practice. Eur J Pain. 2018;22(5):941–50.

    Article  CAS  Google Scholar 

  32. Mankowski C, Poole CD, Ernault E, et al. Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. BMC Neurol. 2017;17(80):1–11.

    Google Scholar 

  33. Galvez R, Navez ML, Moyle G, et al. Capsaicin 8% patch repeat treatment in nondiabetic peripheral neuropathic pain: a 52-week, open-label, single-arm, safety study. Clin J Pain. 2017;33(10):921–31.

    Article  Google Scholar 

  34. Peppin JF, Majors K, Webster LR, et al. Tolerability of NGX-4010, a capsaicin 8% patch for peripheral neuropathic pain. J Pain Res. 2011;4:385–92.

    Article  CAS  Google Scholar 

  35. Abdulahad AK, Snijder RJ, Panni MK, et al. A novel standard to evaluate the impact of therapeutic agents on patient safety: the BURDEN OF THERAPY™©. Contemp Clin Trials Commun. 2016;4:186–91.

    Article  Google Scholar 

  36. Attal N. Pharmacological treatments of neuropathic pain: the latest recommendations. Rev Neurol (Paris). 2019;175(1–2):46–50.

    Article  CAS  Google Scholar 

  37. Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review, meta-analysis and updated NeuPSIG recommendations. Lancet Neurol. 2015;14(2):162–73.

    Article  CAS  Google Scholar 

  38. Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17(9):1113-e88.

    Article  Google Scholar 

  39. Cruccu G, Truini A. A review of neuropathic pain: from guidelines to clinical practice. Pain Ther. 2017;6(Suppl 1):35–42.

    Article  Google Scholar 

  40. Fradkin M, Batash R, Elmaleh S, et al. Management of peripheral neuropathy induced by chemotherapy. Curr Med Chem. 2019;01:07.

    Google Scholar 

  41. Bates D, Schultheis BC, Hanes MC, et al. A comprehensive algorithm for management of neuropathic pain. Pain Med. 2019;20(Suppl 1):S2–12.

    Article  Google Scholar 

  42. German Society for Neurology. Guidelines for diagnosis and therapy in neurology. 2019. https://www.dgn.org/. Accessed 18 Nov 2019.

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Acknowledgements

The article was updated from Drugs 2018;78(14):1489–1500 [9], and was reviewed by: A.R.T.S. Araújo, Department of Pharmacy, School of Health Sciences, Polytechnic Institute of Guarda, Guarda, Portugal; F. Araujo, Department of Pharmacy, Virgen del Rocio Hospital, Seville, Spain; G. Hans, Multidisciplinary Pain Center, Antwerp University Hospital, Edegem, Belgium; F. Rustemi, Department of Pharmacy, Albanian University, Tirane, Albania. During the peer review process, Grünenthal, the marketing-authorization holder of the capsaicin 8% dermal patch, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Sheridan M. Hoy

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Sheridan M. Hoy is an employee of Adis International Ltd./Springer Nature, is responsible for the article content and declares no conflicts of interest.

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Additional information for this Adis Drug Q&A can be found at https://doi.org/10.6084/m9.figshare.11099882.

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Hoy, S.M. Capsaicin 8% dermal patch in peripheral neuropathic pain: a profile of its use. Drugs Ther Perspect 36, 47–56 (2020). https://doi.org/10.1007/s40267-019-00701-0

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