NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study

Bačkonja, Miroslav; Wallace, Mark; Blonsky, E. Richard; Cutler, Barry J; Malan, Philip T.; Rauck, Richard; Tobias, Jeffrey

doi:10.1016/s1474-4422(08)70228-x

Cited by 364 publications

(299 citation statements)

References 20 publications

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“…Randomized controlled studies have demonstrated efficacy and safety of the capsaicin patch in the treatment of PNP (Backonja et al., 2008; Simpson et al., 2008; Irving et al., 2011; Mou et al., 2013), and it is recommended as a second‐line treatment option for the condition, (Finnerup, Attal et al., 2015). …”

Section: Discussionmentioning

confidence: 99%

“…Assessment of the primary endpoint was at Week 8, consistent with Phase III trials of the capsaicin patch conducted in PHN patients (Backonja et al., 2008). This assessment time point has also been used in a number of pregabalin trials (Dworkin et al., 2003; Sabatowski et al., 2004).…”

Section: Methodsmentioning

confidence: 99%

“…As in the capsaicin 8% patch clinical trials (Backonja et al., 2008; Simpson et al., 2008; Irving et al., 2011), a responder was defined as a patient who exhibited a ≥30% decrease in NPRS score from baseline. Baseline scores referred to the mean NPRS scores recorded during the screening period.…”

Section: Methodsmentioning

confidence: 99%

“…A single 60‐min application of a capsaicin 8% patch (hereon referred to as the capsaicin patch) rapidly delivers capsaicin into the skin, directly targeting the nociceptor leading to its defunctionalization (Malmberg et al., 2004; Kennedy et al., 2010; Anand and Bley, 2011). The efficacy and safety of the capsaicin patch in the treatment of PNP is well established (Backonja et al., 2008; Simpson et al., 2008; Irving et al., 2011; Mou et al., 2013) and it is approved for the treatment of PNP in non‐diabetic adults in the EU (QUTENZA ™ , SPC, 2014).…”

Section: Introductionmentioning

confidence: 99%

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Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Haanpää

Cruccu

Nurmikko

et al. 2015

European Journal of Pain

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BackgroundClinical trials have not yet compared the efficacy of capsaicin 8% patch with current standard therapy in peripheral neuropathic pain (PNP).ObjectivesHead‐to‐head efficacy and safety trial comparing the capsaicin patch with pregabalin in PNP.MethodsOpen‐label, randomized, multicentre, non‐inferiority trial. Patients with PNP, aged 18–80 years, were randomly assigned to either the capsaicin 8% patch (n = 282) or an optimised dose of oral pregabalin (n = 277), and assessed for a ≥30% mean decrease in Numeric Pain Rating Scale (NPRS) score from baseline to Week 8. Secondary endpoints included optimal therapeutic effect (OTE), time‐to‐onset of pain relief and treatment satisfaction.ResultsThe capsaicin 8% patch was non‐inferior to pregabalin in achievement of a ≥30% mean decrease in NPRS score from baseline to Week 8 (55.7% vs. 54.5%, respectively; Odds ratio: 1.03 [95% CI: 0.72, 1.50]). The proportion of patients achieving OTE at Week 8 was 52.1% for the capsaicin 8% patch versus 44.8% for pregabalin (difference: 7.3%; 95% CI: −0.9%, 15.6%). The median time‐to‐onset of pain relief was significantly shorter for capsaicin 8% patch versus pregabalin (7.5 vs. 36.0 days; Hazard ratio: 1.68 [95% CI: 1.35, 2.08]; p < 0.0001). Treatment satisfaction was also significantly greater with the capsaicin 8% patch versus pregabalin. TEAEs were mild‐to‐moderate in severity, and resulted in treatment discontinuation only with pregabalin (n = 24). Systemic adverse drug reactions ranged from 0 to 1.1% with capsaicin 8% patch and 2.5 to 18.4% with pregabalin.ConclusionsThe capsaicin 8% patch provided non‐inferior pain relief to an optimized dose of pregabalin in PNP, with a faster onset of action, fewer systemic side effects and greater treatment satisfaction.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Haanpää

Cruccu

Nurmikko

et al. 2015

European Journal of Pain

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“…(Note that, although neuroprotection is the subject of this review, recent clinical trials suggest the opposite approach: using high-concentration topical capsaicin to ablate sensory nerve terminals offers an effective treatment for PHN. 51 ) Ultimately, neuroprotection will be afforded by preventing PHN through vaccination against herpes zoster virus. 52,53 …”

Section: Chemotherapy-induced Peripheral Neuropathymentioning

confidence: 99%

Targeting Neuroprotection as an Alternative Approach to Preventing and Treating Neuropathic Pain

Bordet

Pruss

2009

Neurotherapeutics

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Summary:Neuropathic pain syndromes arise from dysfunction of the nerve itself, through traumatic or nontraumatic injury. Unlike acute pain syndromes, the pain is long-lasting and does not respond to common analgesic therapies. Drugs that disrupt nerve conduction and transmission or central sensitization, currently the only effective treatments, are only modestly effective for a portion of the patients suffering from neuropathic pain and come with the cost of serious adverse effects. Neurodegeneration, as a reaction to nerve trauma or chronic metabolic or chemical intoxication, appears to be an underlying cause of neuropathic pain. Identifying mechanisms of neurodegeneration and designing neuroprotective therapies is an ambitious goal toward treating or even preventing the development of these disabling disorders.

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Topical capsaicin for chronic neuropathic pain in adults

Derry¹,

Moore²,

McQuay³

et al. 2008

Cochrane Database of Systematic Reviews

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Background-Topical creams with capsaicin are used to treat pain from a wide range of chronic conditions including neuropathic pain. Following application to the skin capsaicin causes enhanced sensitivity to noxious stimuli, followed by a period with reduced sensitivity and, after repeated applications, persistent desensitisation. There is uncertainty about the efficacy and tolerability of capsaicin for treating painful chronic neuropathies.

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NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study

Cited by 364 publications

References 20 publications

Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Targeting Neuroprotection as an Alternative Approach to Preventing and Treating Neuropathic Pain

Topical capsaicin for chronic neuropathic pain in adults

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