Qutenza is also undergoing U.S. regulatory review, and the United States Food and Drug Administration (FDA) has scheduled a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009 to review the new drug application (NDA) for the management of pain associated with postherpetic neuralgia (PHN).
Anthony DiTonno, President and CEO, commented, "We are confident that Qutenza is closer than ever to commercialization as we await the European Commission's decision on our MAA, expected within the coming weeks. We are in late stage discussions with potential European commercial partners for Qutenza, supported by the proposed broad E.U. label for peripheral neuropathic pain conditions in non-diabetic adults, either alone or in combination with other medicinal products for pain. We also continue to plan for the potential U.S. commercialization of Qutenza. Our top priority remains to secure U.S. and European regulatory approvals and become a commercial-stage company. We look forward to several upcoming milestones in 2009."
First Quarter 2009 Financial Results
Total operating expenses for the first quarter of 2009 were approximately $4.5 million, down 46% from approximately $8.3 million in the same period of 2008. The decrease primarily resulted from a $3.5 million decrease in research and development costs. Year-over-year operating expenses were lower as the Company deferred development programs in order to focus resources on regulatory processes and to continue preparations for potential commercialization of Qutenza in both Europe and the
|SOURCE NeurogesX, Inc.|
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