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NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)
Date:6/10/2009

complete enrollment, analyze the data, and submit an NDA amendment prior to the assigned PDUFA date. Submission of this amendment during the review cycle may result in an extension of the PDUFA date.

Anthony DiTonno, CEO of NeurogesX, commented, "With the FDA's approval of our protocol, we believe we can quickly complete the requested study and submit an amendment to our NDA. We are hopeful to submit this additional data before our PDUFA date and that any delay in the FDA's decision will be relatively short. We are optimistic that an FDA decision on our NDA may be available before the end of 2009. On the heels of our European approval, we are optimistic about the potential for a near-term announcement of an EU commercial partnership and we look forward to the potential for a Qutenza launch in Europe and potentially the U.S. in the first half of 2010."

About NeurogesX, Inc.

NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate Qutenza, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. NeurogesX submitted a new drug application (NDA) for Qutenza to the U.S. Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and was given a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009.

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