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www.fdanews.com/articles/63446-neurogesx-reports-results-of-post-herpetic-neuralgia-study

NEUROGESX REPORTS RESULTS OF POST-HERPETIC NEURALGIA STUDY

October 23, 2006

NeurogesX has announced positive results from a multicenter, double-blind, controlled Phase III trial of Transacin (NGX-4010), the company's high-concentration trans-capsaicin dermal patch, in patients with post-herpetic neuralgia (PHN). The study met its prespecified primary endpoint with patients reporting statistically significant pain reduction after a single one-hour application of Transacin. A significant reduction in pain was noted during the first week following treatment and was maintained throughout the 12-week study period. At 12 weeks, more than one-half of all subjects treated with Transacin reported improvement in their condition, as measured by the Patient Global Impression of Change scale.

The study was conducted at 53 clinical sites in the U.S. A total of 402 patients suffering from PHN were randomized to a single, one-hour treatment with Transacin or to a matching, low-concentration capsaicin control patch. Study subjects were then followed for 12 weeks. Pain was recorded daily by study subjects using the Numeric Pain Rating Scale of zero (no pain) to 10 (worst possible pain).

Transacin is a topical, physician-administered patch containing a high concentration of trans-capsaicin, a synthetic form of the naturally occurring TRPV1 agonist capsaicin. Unlike current treatment approaches for neuropathic pain that include opioids and other agents -- which act on the central nervous system and can cause drowsiness or other systemic side effects -- the patch is designed to act peripherally in the skin, where the pain frequently originates. The incidence for safety issues or side effects that negatively impact quality of life is expected to be low.