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NeurogesX Completes Enrollment in Confirmatory Phase 3 Clinical Trial for Painful HIV Distal Sensory Polyneuropathy
Date:9/21/2007

SAN CARLOS, Calif., Sept. 21 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX) announced today that it has completed enrollment in study C119, a second Phase 3 clinical trial of its lead product candidate NGX-4010 for the treatment of painful HIV-distal sensory polyneuropathy (HIV-DSP). NGX-4010 is a dermal patch designed to manage peripheral neuropathic pain. Previously completed Phase 3 trials demonstrated that a single, 30- or 60-minute treatment with NGX-4010 applied directly to the site of pain may provide pain relief for up to three months. C119 is a randomized, double-blind, controlled study that has enrolled over 480 patients at study sites in the United States, the United Kingdom, Australia and Canada.

"We believe that completion of enrollment in our C119 study marks a significant milestone in our NGX-4010 development program in HIV-DSP. We are currently in the follow-up phase of the study and expect to be able to provide top-line results near the end of the first quarter of 2008," commented Dr. Jeffery Tobias, Chief Medical Officer. "HIV-DSP is an important and underserved problem in patients with HIV/AIDS. There are currently no approved therapies for this indication. With the completion of enrollment in study C119, we are moving closer to our goal of providing an effective treatment for this patient population."

The study protocol for study C119 evaluates the effect of a single, 30- or 60-minute treatment with NGX-4010 or a low-concentration control patch applied directly to the patient's site of pain. NGX-4010 is administered by a physician during an in-office procedure. After 30 or 60 minutes, the study patch is removed and the patient's response to treatment is evaluated during the su
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