The study evaluated the effect of a single application of NGX-4010 (transacin), the company’s novel high-concentration trans-capsaicin dermal patch, on pain due to HIV-associated sensory neuropathy (HIV-AN). The primary endpoint in this phase III trial was achieved, demonstrating a statistically significant reduction in pain over a 12-week period.
NeurogesX plans to initiate a second phase III trial in HIV-AN in the first half of 2006. Transacin, a neuropathic pain treatment that is clinically administered via a dermal patch, has been granted orphan drug and fast track status for HIV-AN by the FDA.
Transacin has a profile unlike currently available neuropathic pain treatment options, which are associated with systemic side effects and inconvenient dosing regimens. The company has studied the effects of Transacin in more than 500 patients suffering from postherpetic neuralgia, more than 300 patients with HIV-AN and approximately 100 patients with painful diabetic neuropathy with no reported significant safety issues to date.
NeurogesX is currently conducting a pivotal trial with Transacin for the treatment of PHN and plans to initiate a second pivotal trial in painful diabetic neuropathy in the first half of 2006.