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

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In clinical trials, the most common adverse reactions were application site redness, pain, itching, and papules. The majority of these reactions were transient and self limited. Among patients treated with Qutenza, one percent discontinued prematurely due to an adverse event. Serious adverse reactions included application site pain and increased blood pressure. Increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes were on average less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal.

"We are delighted to have received the FDA's approval to provide this novel pain management therapy to the many patients and physicians looking for new ways to manage PHN," said Anthony DiTonno, President and Chief Executive Officer, NeurogesX. "The approval of Qutenza is a tremendous accomplishment for NeurogesX as it represents the culmination of numerous years of hard work and determination by our entire organization. With Qutenza now approved both in the United States and European Union, we expect 2010 will be a great year for NeurogesX as Qutenza is introduced in these major markets."

NeurogesX plans to commercialize Qutenza in the United States through its own sales force and plans for the initial launch of Qutenza in the first half of 2010.

About Postherpetic Neuralgia (PHN)

Postherpetic neuralgia (PHN) is nerve pain that occurs following an attack of shingles. The pain can persist long after the shingles rash clears up and can disrupt sleep, mood, work and activities of daily living. Shingles can damage nerves and the pain from damaged nerves may feel like a sharp, burning, tingling, shooting or numb sensation. The risk of developing PHN increases with age (especially in people over 50) and for patients who experienced severe pain or severe rash during the acute shingles episode.

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SOURCE NeurogesX, Inc.
Copyright©2009 PR Newswire.
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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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