NeurogesX Announces New PDUFA Date for Qutenza New Drug Application

NeurogesX has announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from August 16, 2009 to November 16, 2009 to review the new drug application (NDA) for Qutenza to manage pain associated with postherpetic neuralgia (PHN).

The extension resulted from the company’s recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline.

Anthony DiTonno, president and CEO, said: The FDA’s three-month extension is not unexpected. We previously discussed the potential for this extension as a result of our responses to FDA requests for additional information. The information we submitted in July included the report from our recently completed C123 Study, which was performed at the request of the FDA. We believe that with this updated review timeline, if we gain approval in November, we may still achieve our overall goal of launching Qutenza in the US in the first half of 2010.