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NeurogesX Announces Preliminary Results from Second Phase 3 Clinical Trial in HIV-DSP
Date:2/27/2008

er studies and there was a trend in favor of treatment. We will continue to evaluate whether the cumulative clinical data from our clinical studies may be able to support evidence of efficacy in HIV-DSP."

The study, a multi-center, double-blind, controlled Phase 3 clinical trial in a total of 494 patients, was similar in design to the Company's previous successfully completed phase 3 study in HIV-DSP. Study C119 contained two treatment arms (30-minute and 60-minute arms) for both NGX-4010 and a control patch containing a low concentration of the same active ingredient as NGX- 4010. When looking at the individual treatment arms, the 30-minute group treated with NGX-4010 achieved a 26.1% reduction in pain from baseline compared to 19.1% for the control group (p=0.1) and the 60-minute group treated with NGX-4010 achieved a 32.8% reduction in pain from baseline compared to 30.1% for the control group (p=0.5). Secondary endpoints also did not achieve statistical significance.

Anthony DiTonno, Chief Executive Officer, commented, "We remain focused on our overall goal of achieving commercial launch of NGX-4010 in 2009. We are on track to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) later this year in postherpetic neuralgia (PHN), and are continuing with the Marketing Authorization Application (MAA) under the centralized procedure in the Europe Union where our application for approval was accepted by the European Medicines Agency (EMEA) in September of last year. We expect to consult with both regulatory agencies in the coming weeks to discuss how the results of this most recently completed trial, when taken in the context of the entire clinical development record of NGX-4010, which has been studied in over 1,600 patients, may support gaining an approval broader than the potential PHN indication. "

NGX-4010 is a dermal patch containing capsaicin, a selective TRPV1 agonist, designed to manage peripheral neuropathic p
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SOURCE NeurogesX, Inc.
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