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Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy

From Mount Sinai School of Medicine (D.M.S.), New York, NY; AIDS Research Alliance (S.B.), West Hollywood, CA; and NeurogesX, Inc. (J.T.), San Carlos, CA.

Address correspondence and reprint requests to Dr. David M. Simpson, Professor of Neurology, Director, Clinical Neurophysiology Laboratories and Neuro-AIDS Program, The Mount Sinai Medical Center, Box 1052, New York, NY 10029 david.simpson{at}mssm.edu.

Background: HIV-associated distal sensory polyneuropathy (HIV-DSP) is a painful condition with limited effective treatment. Capsaicin desensitizes cutaneous nociceptors resulting in reduced pain. We report a placebo-controlled study of a high-concentration capsaicin dermal patch (NGX-4010) for the treatment of painful HIV-DSP.

Methods: This double-blind multicenter study randomized 307 patients with painful HIV-DSP to receive NGX-4010 or control, a low-concentration capsaicin patch. After application of a topical anesthetic, NGX-4010 or control was applied once for 30, 60, or 90 minutes to painful areas on the feet. The primary efficacy endpoint was percent change in Numeric Pain Rating Scale (NPRS) from baseline in mean "average pain for past 24 hours" scores from weeks 2 to 12.

Results: A single NGX-4010 application resulted in a mean pain reduction of 22.8% during weeks 2 to 12 as compared to a 10.7% reduction for controls (p = 0.0026). Following a transient treatment-related pain increase, pain was reduced; significant improvement was apparent by week 2 and continued throughout the controlled 12-week observation period. Mean pain reductions in the NGX-4010 30-, 60- and 90-minute groups were 27.7%, 15.9%, and 24.7% (p = 0.0007, 0.287, and 0.0046 vs control). One third of NGX-4010-treated patients reported 30% pain decrease from baseline as compared to 18% of controls (p = 0.0092). Self-limited, mild-to-moderate local skin reactions were commonly observed.

Conclusions: A single NGX-4010 application was safe and provided at least 12 weeks of pain reduction in patients with HIV-associated distal sensory polyneuropathy. These results suggest that NGX-4010 could provide a promising new treatment for painful HIV neuropathy.

Abbreviations: AEs = adverse events;ARV = antiretroviral; BPI = Brief Pain Inventory; CGIC = Clinician Global Impression of Change; HIV-DSP = HIV-associated distal sensory polyneuropathy; NPRS = Numeric Pain Rating Scale; PGIC = Patient Global Impression of Change.

*Members of the NGX-4010 C107 Study Group are listed in the appendix.

This study is registered in www.clintrials.gov as number NCT00064623.

Disclosures: David Simpson has consulted for NeurogesX, Inc.; Jeffrey Tobias is a full-time employee of and holds stock options from NeurogesX, Inc.; Stephen Brown has nothing to disclose.

Received September 26, 2007. Accepted in final form March 3, 2008.