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NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental new drug application (sNDA) for Qutenza(NYSE:R) (capsaicin) 8% for the management of neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN). The FDA has granted Qutenza a priority six month review classification, assigning a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2012.

"The FDA's filing and priority review of our sNDA for Qutenza in HIV-PN is a significant achievement for NeurogesX as we seek to expand our pain management franchise," said Anthony DiTonno, President and CEO of NeurogesX. "This takes us another step forward in our effort to provide lasting relief from one of the most challenging chronic pain conditions. We look forward to our continued discussion with the FDA during the review of this application."

The Qutenza sNDA seeks approval for a 30-minute application for the treatment of neuropathic pain associated with HIV-PN. Qutenza is currently FDA approved as a 60-minute application for the management of neuropathic pain associated with postherpetic neuralgia (PHN). If approved, the company believes that Qutenza would be the first and only product approved to treat HIV-PN in the United States.

HIV-PN is the most common neurological complication of HIV infection. Many patients with HIV are afflicted with symptoms ranging from mild tingling to severe and excruciating pain. HIV-PN is thought to be caused by multiple factors related to HIV infection including injury of sensory neurons by HIV virus proteins, the immune system's fight against HIV and some antiretroviral drugs.

NeurogesX, Inc. is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.

More about NGSX at www.neurogesx.com

Read full article at: http://stock-pr.com/?p=20697

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