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NeurogesX Receives FDA Approval of Qutenza(TM) (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
Date:11/16/2009

SAN MATEO, Calif., Nov. 16 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX) announced today that the U.S. Food and Drug Administration (FDA) has approved Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. Qutenza delivers a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation, through a dermal delivery system, providing up to 12 weeks of reduced pain following a single one-hour application. It is the first product from NeurogesX to be approved by the FDA.

"PHN can be an excruciatingly painful condition that can affect many aspects of a patient's quality of life. Despite a variety of medications for pain, undesirable side effects often limit their use and therefore, the treatment of PHN continues to represent a significant unmet need," said Lynn Webster, M.D., Medical Director, Lifetree Clinical Research, Salt Lake City, Utah. "Qutenza may provide a unique treatment option that works at the site of the pain and may be useful as a treatment option in combination with existing therapies."

Qutenza works by targeting certain pain nerves in the area of skin where pain is being experienced. The Qutenza patch is applied by a physician or a healthcare professional. Clinical studies have shown that PHN pain can be reduced for up to 12 weeks following a single one-hour treatment. Up to four patches may be used and patches may be cut to conform to the size and shape of the painful area. Qutenza is a locally-acting, non-narcotic medication that is unlikely to cause drowsiness or have drug-drug interactions. Treatment with Qutenza may be repeated every three or more months as warranted by the return of pain. <
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SOURCE NeurogesX, Inc.
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4. NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study
5. NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
6. NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by The Lancet Neurology
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