Clinical Studies
NGX-4010 is our first product candidate. It provides application of a pure high concentration form of synthetic capsaicin, known as
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 Digital 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 approximately equally among the 30, 60 and 90 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).