Capsaicin Dermal Patch
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Capsaicin dermal patch is an adhesive patch containing a high concentration (8% w/w) of synthetic capsaicin. It is indicated in the EU for the treatment of peripheral neuropathic pain in non-diabetic adults using a single 30- or 60-minute application repeated every 90 days, as required, and in the US for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN).
In pivotal, randomized, double-blind, multicentre trials in adults with PHN, a single 60-minute application of capsaicin dermal patch reduced the mean Numeric Pain Rating Scale (NPRS) scores from baseline to a significantly greater extent than a low-concentration (0.04% w/w capsaicin) control patch during weeks 2–8.
In randomized, double-blind, multicentre trials in patients with HIV-associated neuropathy, capsaicin dermal patch reduced the mean NPRS scores from baseline significantly more than control in one study for the 30- and 90-minute, but not the 60-minute, application during weeks 2–12. In another study, the differences between capsaicin (30- and 60-minute applications) and control did not reach statistical significance. An integrated analysis of both studies showed that the 30-minute application of capsaicin dermal patch was significantly better than control for the reduction from baseline in mean NPRS scores during weeks 2–12.
The efficacy of capsaicin dermal patch was maintained for up to 1 year in extension studies in which patients could receive up to three or four repeat treatments.
Capsaicin dermal patch was generally well tolerated in clinical trials. The most common adverse events were transient, mostly mild to moderate, application-site reactions.
- 10.European Medicines Agency. Qutenza (capsaicin) 179 mg cutaneous patch: summary of product characteristics [online]. Available from URL: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Qutenza/emea-combined-h909en.pdf [Accessed 2010 Jun 21]
- 11.NeurogesX Inc. Qutenza (capsaicin) 8% patch: US prescribing information [online]. Available from URL: http://www.qutenza.com/_docs/qutenza_full_PI_.pdf [Accessed 2010 Jun 24]
- 13.European Medicines Agency. CHMP Assessment Report for Qutenza [online]. Available from URL: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Qutenza/H-909-en6.pdf [Accessed 2010 Jun 14]
- 19.Webster LR, Malan TP, Tuchman MM, et al. A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. J Pain. Epub 2010 Jul22Google Scholar
- 22.Backonja MM, Dunteman E, Irving GA, et al. One 60-minute application of a high-concentration capsaicin patch (NGX-4010) significantly reduced pain for up to 3 months in patients with postherpetic neuralgia: results from a randomized, double-blind, controlled phase 3 study [abstract no. P03.149]. Neurology 2008 Mar 11; 70 Suppl. 1: A162–3Google Scholar
- 23.Clifford D, Simpson D, Brown S, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of painful HIV-associated distal sensory polyneuropathy [abstract no. 411 plus poster]. 17th Conference on Retroviruses and Opportunistic Infections; 2010 Feb 16–19; San Francisco (CA)Google Scholar
- 24.US FDA Center for Drug Evaluation and Research. Medical review: Qutenza (capsaicin patch 8%) [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395s000Medr.pdf [Accessed 2010 Aug 13]
- 25.Backonja MM, Irving GA, Webster LR, et al. Efficacy of Qutenza™ (NGX-4010), a high-concentration capsaicin cutaneous patch, in patients with peripheral neuropathic pain: results of integrated analyses [abstract no. P1046]. Eur J Neurol 2009; 16 Suppl. 3: 71Google Scholar
- 26.Simpson D, Brown S, Tobias J, et al. Treatment of painful HIV-associated distal sensory polyneuropathy with a high-concentration capsaicin dermal patch (NGX-4010): report of a 52-week study [abstract no. S50.001]. Neurology 2007 Mar 20; 68 Suppl. 1: 346–7Google Scholar
- 27.Webster LR, Malan TP, Tuchman M. Duration of treatment response to NGX-4010, a high-concentration capsaicin patch, in patients with postherpetic neuralgia [abstract no. 303]. 29th Annual Scientific Meeting of the American Pain Society; 2010 May 6–8; Baltimore (MD)Google Scholar
- 28.Simpson D, Brown S, Chang S, et al. Long-term intermittent treatment with high-concentration capsaicin dermal patch (CDP, NGX-4010) for painful HIV-associated distal sensory polyneuropathy (DSP) [abstract no. THPE0073]. 16th International AIDS Conference; 2006 Aug 13–18; Mexico CityGoogle Scholar