NeurogesX Reports Preliminary Results Of FDA-Requested Qutenza Study

NeurogesX has reported the preliminary results of a short-term clinical study (Study C123) of Qutenza in patients with postherpetic neuralgia (PHN), following pretreatment with an FDA-approved topical anesthetic.

As part of the ongoing new drug application (NDA) review, 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.

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

Reportedly, the preliminary results of Study C123 showed that 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, said the company.

NeurogesX expects to provide results from Study C123 to FDA, prior to the PDUFA date of August 16, 2009.

Jeffrey Tobias, CMO at NeurogesX, said: 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 topical anesthetic as part of the Qutenza treatment procedure.