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NeurogesX Reports Third Quarter 2008 Results
Date:11/6/2008

X submitted a new drug application (NDA) for NGX-4010 with the U.S. Food and Drug Administration (FDA) in October 2008 for PHN, which is subject to acceptance by the FDA. Additionally, a marketing authorization application (MAA) for NGX-4010 seeking approval for peripheral neuropathic pain is currently under review by the European Medicines Agency (EMEA).

NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 is currently in a Phase 1 clinical trial. The objective of the development program for NGX-1998 is to determine its ability to provide protracted pain relief from a single treatment. As a liquid, NGX-1998 is expected to be suitable for areas of the skin where dermal patches may be difficult or impractical to apply, such as the hairline. NGX-1998 is being developed with the goal of it becoming a product that has the potential to be used by a broad spectrum of the physician population. NGX-1998 was previously studied in two Phase 1 studies in healthy volunteers conducted under an exploratory investigational new drug application.

Safe Harbor Statement

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, possible approval of NeurogesX' product candidates by the FDA or EMEA; estimations of the PDUFA date timing; plans and ability for commercial launch of NGX-4010; the sufficiency of cash resources to fund operations into 2010; plans for, and the potential timing of, establishment of commercialization partnerships in Europe and the United States, and th
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SOURCE NeurogesX, Inc.
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