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

bsequent 12-week study period.

Anthony A. DiTonno, President and CEO, commented, "I am very pleased with our ability to complete the enrollment of this study ahead of plan. When we completed our initial public offering earlier this year, we indicated that we would file a new drug application (NDA) with the Food and Drug Administration (FDA) in the second half of 2008. Completion of enrollment in this study, on top of our three already completed successful Phase 3 trials, increases our confidence that we can meet this goal."

NeurogesX has successfully completed two Phase 3 studies in postherpetic neuralgia (PHN) and one in HIV-DSP. NGX-4010 has been granted orphan status and has received fast track designation from the FDA for HIV-DSP. NeurogesX believes that it is on track to file for marketing approval in the European Union before the end of 2007 for a broad indication of peripheral neuropathic pain. The Company is currently evaluating various regulatory filing strategies in the United States in order to most efficiently seek FDA approval of both the PHN and HIV-DSP indications, and believes that it will be able to submit a new drug application with the FDA in 2008.

About PHN and HIV-DSP

PHN is a painful condition affecting sensory nerve fibers. It is a complication of shingles, a second outbreak of the varicella-zoster virus, which initially causes chickenpox. Following an initial infection, some of the virus can remain dormant in nerve cells. Years later, age, illness, stress, medications or other factors that are not well understood can lead to reactivation of the virus. The rash and blisters associated with shingles usually heal within six weeks, but some people continue to experience pain for years thereafter. This pain is known as postherpetic neuralgia. PHN may occur in almost any area, but is especially common on the torso.

HIV-DSP is caused primarily by three factors: direct activation of cells known as sensory neurons by the
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SOURCE NeurogesX, Inc.
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