NeurogesX Announces Preliminary Results of FDA-Requested Qutenza...( SAN MATEO Calif. July 24 /- Neu...),Health

SAN MATEO, Calif., July 24 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX) announced today the preliminary results of a short-term clinical study (Study C123) of Qutenza(TM) in patients with postherpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. As part of the ongoing new drug application (NDA) review, the U.S. Food and Drug Administration (FDA) requested the study 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 NDA for Qutenza in PHN has a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009.

In Study C123, 24 patients received a single 60-minute Qutenza patch application following a 60-minute pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine). The mean duration of patch application was evaluated as the primary endpoint analysis. Patients were monitored for seven days following treatment.

Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes. No patients removed the Qutenza patch prematurely (i.e.< 90% of the intended full application time).

The company expects to provide results from Study C123 to the FDA prior to the PDUFA date of August 16, 2009. The impact on the agency's timing, if any, for an ultimate decision on the NDA is not yet known.

Dr. Jeffrey Tobias, NeurogesX' Chief Medical Officer commented, "I am grateful to our clinical investigators and the entire NeurogesX team for working together to quickly complete this study. We believe that these results will address the FDA's questions relating to the use of an FDA-approved to
'/>"/>