NGX-4010

Beyond conventional pain therapy

NGX-4010 is our first product candidate. It provides application of a pure high concentration form of synthetic capsaicin, known as trans-capsaicin, directly to the site of pain via a rapid-delivery cutaneous (skin) patch application system. Findings from clinical trials suggest that a single topical application of NGX-4010 may provide three months of pain relief with minimal potential for side effects or drug-drug interactions.

Clinical Studies

NeurogesX has conducted Phase 3 clinical studies in the use of NGX-4010 for the potential treatment of neuropathic pain.

Postherpetic Neuralgia (PHN)
A total of 402 patients with PHN were enrolled in a randomized, double-blind, controlled Phase 3 study of the NGX-4010 (trans-capsaicin, 8% w/w) patch for the treatment of PHN. The treatment consisted of a single one-hour patch application of NGX-4010 or a low-concentration capsaicin control applied to the area of the skin described as painful, following pretreatment with topical local anesthetic. Painful areas up to a total surface area of 1,000 cm² were treated. Efficacy and safety were assessed over 12 weeks. Efficacy was assessed by daily pain intensity scores on the 11-point scale Numeric Pain Rating Scale (NPRS). The primary efficacy endpoint, defined as the % change from baseline in "average pain" (mean of weeks 2-8), was met (p = 0.001).

Painful HIV-Associated Distal Sensory Polyneuropathy (HIV-DSP)
A total of 307 subjects with moderate to severe pain in both feet from HIV-DSP were enrolled in a randomized double-blind (DB) controlled Phase 3 of the NGX-4010 (trans-capsaicin 8% w/w) patch for HIV-DSP. The treatment consisted of a single one-hour patch application of NGX-4010 or a low-concentration capsaicin control applied to the area of the skin described as painful, following pretreatment with topical local anesthetic. The 307 subjects were divided among the 30-, 60- and 90-minute dose levels. Painful areas up to a total surface area of 1,000 cm² were treated. Efficacy and safety were assessed over 12 weeks. Efficacy was assessed by daily pain intensity scores on the 11-point scale Numeric Pain Rating Scale (NPRS). The primary efficacy endpoint, defined as the % change from baseline in "average pain" (mean of weeks 2-12), was met (p = 0.0026).