NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy

Simpson, David M.; Brown, Stephen J.; Tobias, Jeffrey; Vanhove, Geertrui F.; Martin, Mollen; Sampson, James H.; Gazda, Suzanne; Brand, David W.; Cutler, Barry J; Clifford, David B.; Colson, Amy E.; Ellis, Ronald J.; Drusano, George L.; Valcour, Victor; Borkert, Claire; McComsey, Grace A.; Bartt, Russell; Jesus, Edwin De; Morris, Ann B.; Myers, Robert A.; Teinhart, Corklin; So, Yuen T.; Berger, Joe; Hall, Colin D.; McArthur, Justin C.; Rubin, Michael; Tselis, Alex; Castro, José G.; Rider, Dean; Brinson, Cynthia; Artin, Harold; Pierone, Gerald; Diaz, Leslie

doi:10.1097/ajp.0b013e318287a32f

Cited by 38 publications

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“…Many authors have reported the efficacy,37–47 safety, and tolerability46,48–53 of a single application of capsaicin 8% patch (Qutenza), a high-dose topical formulation for the treatment of peripheral neuropathic pain. Capsaicin, the pungent “hot” ingredient in chili peppers, is a natural selective agonist of the vanilloid receptor TRPV1.…”

Section: Introductionmentioning

confidence: 99%

“…It is released rapidly from the capsaicin 8% patch, and leads to overstimulation of the skin TRPV1 nociceptors which are “defunctionalized” and are no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain 54. A single application of capsaicin 8% patch can provide pain relief for up to 3 months or more,37–47 without the systemic side effects seen with other pain treatments,46,48–53 with the maximum effect reached within 1–2 weeks from the application 54. Capsaicin 8% patch has been shown in a previous study to reduce the intensity of amputation stump and phantom limb pain,55 but sensory and brain mechanisms have not been studied.…”

Section: Introductionmentioning

confidence: 99%

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Capsaicin 8% patch treatment for amputation stump and phantom limb pain: a clinical and functional MRI study

Privitera¹,

Birch²,

Sinisi³

et al. 2017

JPR

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PurposeThe aim of this study was to measure the efficacy of a single 60 min application of capsaicin 8% patch in reducing chronic amputation stump and phantom limb pain, associated hypersensitivity with quantitative sensory testing, and changes in brain cortical maps using functional MRI (fMRI) scans.MethodsA capsaicin 8% patch (Qutenza) treatment study was conducted on 14 patients with single limb amputation, who reported pain intensity on the Numerical Pain Rating Scale ≥4/10 for chronic stump or phantom limb pain. Pain assessments, quantitative sensory testing, and fMRI (for the lip pursing task) were performed at baseline and 4 weeks after application of capsaicin 8% patch to the amputation stump. The shift into the hand representation area of the cerebral cortex with the lip pursing task has been correlated with phantom limb pain intensity in previous studies, and was the fMRI clinical model for cortical plasticity used in this study.ResultsThe mean reduction in spontaneous amputation stump pain, phantom limb pain, and evoked stump pain were −1.007 (p=0.028), −1.414 (p=0.018), and −2.029 (p=0.007), respectively. The areas of brush allodynia and pinprick hypersensitivity in the amputation stump showed marked decreases: −165 cm2, −80% (p=0.001) and −132 cm2, −72% (p=0.001), respectively. fMRI analyses provided objective evidence of the restoration of the brain map, that is, reversal of the shift into the hand representation of the cerebral cortex with the lip pursing task (p<0.05).ConclusionThe results show that capsaicin 8% patch treatment leads to significant reduction in chronic pain and, particularly, in the area of stump hypersensitivity, which may enable patients to wear prostheses, thereby improving mobility and rehabilitation. Phantom limb pain (“central” pain) and associated brain plasticity may be modulated by peripheral inputs, as they can be ameliorated by the peripherally restricted effect of the capsaicin 8% patch.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Capsaicin 8% patch treatment for amputation stump and phantom limb pain: a clinical and functional MRI study

Privitera¹,

Birch²,

Sinisi³

et al. 2017

JPR

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“…The studies performed by Ellis et al [36] and Shiffito et al [51] didn't include ART therapy status in the inclusion criteria. Regarding missing data management only one study followed a baseline observation carried forward practice (Simpson et al [54]), while last observation carried forward method was used in 9 studies (Clifford et al [37], Simpson et al [33], Simpson et al [38], Evans et al [50], Youle et al [47], Simpson et al [40], McArthur et al [46], Kieburtz et al [43], Simpson et al [49]) and a per protocol analysis in 5 (Dinat et al [42], Harrison et al [16], Abrams et al [35], Simpson et al [41], Kemper et al [44]).…”

Section: Participantsmentioning

confidence: 99%

“…Fifteen different drugs were evaluated for efficacy and safety, including Amitriptyline (Dinat et al [42], Shlay et al [32], Kieburtz et al [43]), Pregabalin (Simpson et al [54], Simpson et al [53]), Duloxetine and Methadone (Harrison et al [16]), Capsaicin (Clifford et al [37], Simpson et al [38], Paice et al [27,39]), Smoked cannabis (Ellis et al [36], Abrams et al [35]), Prosaptide (Evans et al [50]), L-Carnitine (Youle et al [47]), Memantine (Shiffito et al [51]), Lidocaine gel (Estanislao et al [48]) Gabapentin (Hanh et al [45]), Lamotrigine (Simpson et al [40], Simpson et al [41]), NGF (McArthur et al [46]), Mexiletine (Kieburtz et al [43], Kemper et al [44]) and Peptide T (Simpson et al [49]). All studies, except for Harrison et al [16] and Kieburtz et al [43], used a placebo group for comparison.…”

Section: Interventionsmentioning

confidence: 99%

Pharmacologic and Non-Pharmacologic Interventions for HIV-Neuropathy Pain. A Systematic Review and a Meta-Analysis

et al. 2019

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Background and Objectives: Among HIV infection symptoms, sensory neuropathy (HIV-SN) remains a main cause of suffering, with incidence varying from 13–50%. So far, numerous pharmacological and non-pharmacological treatments have been tested, although few evidence-based analgesic options are available. We conducted an up-to-date systematic review and meta-analysis of the literature in order to evaluate the efficacy and safety of pharmacologic and non-pharmacologic treatments for pain control, in patients with HIV neuropathy. Materials and Methods: We searched MEDLINE, EMBASE, Scopus/Elsevier, The Cochrane Central Register of Controlled Trials (CENTRAL), USA Clinical Trials registry, and The International Web of Science up to April 2019. All randomized controlled trials evaluating efficacy and safety of non-pharmacologic and pharmacologic therapies were included. Efficacy was defined as pain reduction during the study period. Safety was estimated from adverse events. A meta-analysis was performed whenever possible. Results: 27 randomized controlled trials (RCTs) were included for analysis (7 evaluating non pharmacologic interventions, 20 pharmacologic therapies). Non-pharmacologic studies (n = 742) involved seven different therapeutic modalities. Only Acupuncture/Moxibustion showed pain reduction over placebo, Gracely Pain Scale Mean (SD): Acu/Moxa 0.85 (0.12), placebo 1.10 (0.09), p = 0.05. Pharmacologic studies, involving 2516 patients revealed efficacy for capsaicin 8% over placebo (mean difference −8.04 [95% CI: −14.92 −1.15], smoked cannabis (where pooling data for meta-analysis was not possible) and recombinant Nerve Growth Factor. Conclusion: Despite various modalities for pain control in HIV-SN, strongest evidence exists for capsaicin 8% and smoked cannabis, although of low methodological quality. Among non-pharmacologic modalities, only Acu/Moxa gave a marginal beneficial effect in one study, possibly limited by inherent methodological flaws.

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“…Capsaicin has been investigated as a topical application for diabetic [325][326][327][328][329] and HIV peripheral neuropathy [330][331][332]. The majority of studies have been conducted on diabetes PN with most resulting in statistical significance [325][326][327][328][329].…”

Section: -114mentioning

confidence: 99%

A pilot clinical trial assessing the efficacy and safety of supplementation with a B complex vitamin to reduce the incidence of chemotherapy induced peripheral neuropathy in patients diagnosed with a malignancy

Schloss¹

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NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy

Abstract: Repeated NGX-4010 treatments were generally well tolerated and resulted in consistent reductions in HIV-DSP-associated pain and improvement in patient-reported outcomes.

Cited by 38 publications

References 32 publications

Capsaicin 8% patch treatment for amputation stump and phantom limb pain: a clinical and functional MRI study

Capsaicin 8% patch treatment for amputation stump and phantom limb pain: a clinical and functional MRI study

Pharmacologic and Non-Pharmacologic Interventions for HIV-Neuropathy Pain. A Systematic Review and a Meta-Analysis

A pilot clinical trial assessing the efficacy and safety of supplementation with a B complex vitamin to reduce the incidence of chemotherapy induced peripheral neuropathy in patients diagnosed with a malignancy

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