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

Brown, Stephen, Simpson, David M, Moyle, Graeme, Brew, Bruce J, Schifitto, Giovanni, Larbalestier, Nicholas, Orkin, Chloe, Fisher, Martin, Vanhove, Geertrui F and Tobias, Jeffrey K (2013) 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 Research and Therapy, 10 (5). pp. 1-12. ISSN 1742-6405

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Abstract

BACKGROUND

HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection. NGX-4010 is a capsaicin 8% dermal patch with demonstrated efficacy in the treatment of HIV-DSP. Data from two phase III, double-blind studies were integrated to further analyze the efficacy and safety of NGX-4010 and explore the effect of demographic and baseline factors on NGX-4010 treatment in HIV-DSP.

METHODS

Data from two similarly designed studies in which patients with HIV-DSP received NGX-4010 or a low-concentration control patch (capsaicin 0.04% w/w) for 30 or 60 minutes were integrated. Efficacy assessments included the mean percent change from baseline in Numeric Pain Rating Scale (NPRS) scores to Weeks 2-12. Safety and tolerability assessments included adverse events (AEs) and pain during and after treatment.

RESULTS

Patients (n = 239) treated with NGX-4010 for 30 minutes demonstrated significantly (p = 0.0026) greater pain relief compared with controls (n = 100); the mean percent change in NPRS scores from baseline to Weeks 2-12 was -27.0% versus -15.7%, respectively. Patients who received a 60-minute application of NGX-4010 (n = 243) showed comparable pain reductions (-27.5%) to patients treated for 30 minutes, but this was not statistically superior to controls (n = 115). NGX-4010 was effective regardless of gender, baseline pain score, duration of HIV-DSP, or use of concomitant neuropathic pain medication, although NGX-4010 efficacy was greater in patients not receiving concomitant neuropathic pain medications. NGX-4010 was well tolerated; the most common AEs were application-site pain and erythema, and most AEs were mild to moderate. The transient increase in pain associated with NGX-4010 treatment decreased the day after treatment and returned to baseline by Day 2.

CONCLUSIONS

A single 30-minute application of NGX-4010 provides significant pain relief for at least 12 weeks in patients with HIV-DSP and is well tolerated.

TRIAL REGISTRATION

C107 = NCT00064623; C119 = NCT00321672.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Division of Medical Education
Subjects: R Medicine > RC Internal medicine > RC0109 Infectious and parasitic diseases
Related URLs:
Depositing User: Ellen Thomas
Date Deposited: 19 Aug 2013 10:03
Last Modified: 14 Mar 2017 20:42
URI: http://sro.sussex.ac.uk/id/eprint/45868

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