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NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by The Lancet Neurology
Date:1/12/2009

SAN MATEO, Calif., Jan. 12 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today the publication of Phase 3 data of its lead product candidate, Qutenza (NGX-4010), for the treatment of postherpetic neuralgia (PHN) in the December 2008 print edition of The Lancet Neurology. The article is also available through Lancet Online at http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(08)70228-X/fulltext.

The U.S. Food and Drug Administration (FDA) recently accepted for filing the Company's new drug application (NDA) requesting approval of Qutenza for the management of pain associated with PHN. A marketing authorization application (MAA) for Qutenza is also under review by the European Medicines Agency (EMEA) for the management of peripheral neuropathic pain.

The paper in The Lancet Neurology titled, "NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, doubleblind study," presented results from NeurogesX' pivotal Phase 3 study (study C116). The initial results from this study were announced in October 2006.

The study randomized 402 patients between 18-90 years of age to receive either one 60-minute application of Qutenza (n=206) or a low-concentration capsaicin control patch (n=196). Patients were required to have had PHN for at least six months prior to enrollment, with an average baseline pain rating scale (NPRS) score ranging from three to nine. The study successfully met its primary endpoint by showing a significantly greater percentage reduction in NPRS score from Baseline to Weeks two throu
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SOURCE NeurogesX, Inc.
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