NeurogesX Reports Second Quarter 20...( including the European Union Iceland No...)

In the U.S., the Company actively responded to the FDA's various inquiries and requests for data and analyses as part of the ongoing new drug application (NDA) review for Qutenza in postherpetic neuralgia (PHN). These requests included a short-term Qutenza study (Study C123) to determine whether an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program. The study, conducted in patients with PHN, showed a mean duration of patch application of 60.2 minutes, versus the target application of 60 minutes. The submission of additional information to the FDA in late July, including the study report for Study C123, was classified as a major amendment by the FDA. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline. On August 5, 2009 the FDA notified the Company that it was extending the PDUFA date from August 16, 2009 to November 16, 2009 (or 3 months) to provide time for a full review of the submission.

With the PDUFA date approaching, NeurogesX continued with certain U.S. pre-commercialization activities for Qutenza during the second quarter of 2009, including a meeting with the Centers for Medicare and Medicaid Services (CMS) to discuss U.S. reimbursement. The Company is also evaluating metrics to help size its own U.S. specialty sales force, and remains in active discussions regarding a potential U.S. co-promotion agreement.

Anthony DiTonno, President and CEO, commented, "The second quarter of 2009 was our most significant three-month period to date. With the marketing authorization of Qutenza in Europe we significantly advanced our progression into a commercial company while finalizing our pa
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