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NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
Date:6/2/2009

Potential Seven Years Market Exclusivity in PHN Pending Product Approval

SAN MATEO, Calif., June 2 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the Office of Orphan Product Development (OOPD) of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Qutenza(TM) (formerly NGX-4010), a high concentration capsaicin dermal patch for the management of neuropathic pain in patients with postherpetic neuralgia (PHN).

The FDA is currently reviewing the Company's new drug application (NDA) for Qutenza in PHN and has assigned a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009. Qutenza, if approved by the FDA, would benefit from seven years of market exclusivity in PHN as a result of this orphan designation.

The U.S. Orphan Drug Act encourages the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of rare diseases and conditions affecting 200,000 patients or less. Orphan drug designation is an important economic incentive for the development of new products, providing seven years of exclusive marketing rights during which the FDA will not approve the same drug from another sponsor for the same orphan indication during the exclusivity period. In addition, orphan designation allows for reduction in certain regulatory fees, and additional regulatory support for R&D initiatives.

Anthony DiTonno, President and CEO, commented, "The FDA's orphan designation underscores the unmet need of patients suffering from PHN and may serve to strengthen Qutenza's competitive position through seven years of market exclusivity upon approval."

PHN is a chronic painful condition that develop
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SOURCE NeurogesX, Inc.
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