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A Randomized, Double-Blind, Controlled Study of NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy
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JAIDS Journal of Acquired Immune Deficiency Syndromes: POST ACCEPTANCE, 7 November 2011 Clifford, David B. MD; Simpson, David M. MD; Brown, Stephen MD; Moyle, Graeme MD; Brew, Bruce J. MD; Conway, Brian MD; Tobias, Jeffrey K. MD; Vanhove, Geertrui F. MD, PhD; for the NGX-4010 C119 Study Group


Introduction: Effective treatment of HIV-associated distal sensory polyneuropathy (HIV-DSP) remains a significant unmet therapeutic need. Methods: In this randomized, double-blind, controlled study, patients with pain due to HIV-DSP received a single 30- or 60-minute application of NGX 4010 - a capsaicin 8% patch (n=332) - or a low-dose capsaicin (0.04%) control patch (n=162). The primary endpoint was the mean percent change from baseline in Numeric Pain Rating Scale (NPRS) score to weeks 2-12. Secondary endpoints included Patient Global Impression of Change (PGIC) at week 12.

Results: Pain reduction was not significantly different between the total NGX-4010 group (-29.5%) and the total control group (24.5%; p=0.097). Greater pain reduction in the 60-minute (30.0%) vs. the 30-minute control group (19.1%) prevented intended pooling of the control groups to test individual NGX-4010 treatment groups. No significant pain reduction was observed for the 30-minute NGX-4010 group compared with 30-minute control (26.2% vs. 19.1%, respectively, p=0.103). Pain reductions in the 60-minute NGX-4010 and control groups were comparable (32.8% vs. 30.0%, respectively; p=0.488). Posthoc non-parametric testing demonstrated significant differences favoring the total (p=0.044) and 30-minute NGX-4010 groups (p=0.035). Significantly more patients in the total and 30-minute NGX-4010 group felt improved on the PGIC vs. control (67% vs. 55%, p=0.011 and 65% vs. 45%, p=0.006, respectively). Mild to moderate, transient application site pain and erythema were the most common adverse events.

Conclusions: While the primary endpoint analyses were not significant, trends toward pain improvement were observed following a single 30-minute NGX-4010 treatment.
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