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Title: Experimental Capsaicin 8% Patch Shows Efficacy in Neuropathic Pain: Presented at AAPM

"Experimental Capsaicin 8% Patch Shows Efficacy in Neuropathic Pain: Presented at AAPM"

By Ric Susman KISSIMMEE, FL -- February 18, 2008 -- An hour's use of the experimental NGX-4010 patch containing capsaicin 8% can significantly reduce neuropathic pain compared with a low-concentration patch with capsaicin 0.04%, and that pain relief can be maintained for at least as long as 12 weeks for individuals with postherpetic neuralgia. Miroslav Misha Backonja, MD, Professor of Neurology, Anaesthesiology, and Rehabilitation Medicine, University of Wisconsin at Madison, Madison, Wisconsin, United States, found a significant difference in pain relief with the new drug compared with the low-concentration dose of capsaicin. Dr. Backonja and colleagues found more NGX-4010 subjects who reported being "improved" or "very much improved" compared with control subjects both at week 8 (37% vs 26%,[ P = .0204) and at week 12 (41% vs 26%, P = .0014).

Dr. Backonja presented the findings at a poster presentation on February 15 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

In Dr. Backonja's study, researchers assigned 212 patients to receive the NGX-4010 patch and 204 patients to receive the control patch containing capsaicin 0.04%. The mean age of patients in the study was about 70 years of age. Of the patients in the NGX-4010 arm, 93% were Caucasian men, compared with 94% in the placebo group.

Inclusion criteria were lesion healing and an average pain score between 3 and 9 on the daily 11-point Numeric Pain Rating Scale (NPRS). More than half of the patients were on stable doses of oral neuropathic pain prescription medications. The patients had suffered their attacks of herpes zoster about 6 months earlier, but now suffered from common postherpetic neuralgia.

Patients recorded their average pain score for the 24 hours before administration of the patch. Response was defined as a greater than 30% decrease in the NPRS score from baseline.

NGX-4010 treatment was associated with a statistically greater proportion of responders compared with the control group during weeks 2 through 8 of the study, Dr. Backonja said.

"This study confirms previous phase 3 findings of significant pain relief that lasted 12 weeks in patients with postherpetic neuralgia following a single 60-minute application of NGX-4010," he concluded.

Funding for this study was provided by NeurogesX, Inc.

[Presentation title: A Single One-Hour Application of NGX-4010 Significantly Reduced Pain Scores for Up to 12 Weeks: Results of a Second Randomized, Double-Blind Controlled Study With Postherpetic Neuralgia. Abstract 213]

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