NeurogesX, Inc. (NGSX) announced the preliminary results of a short-term clinical study of Qutenza in patients with postherpetic neuralgia following pretreatment with an FDA-approved topical anesthetic. As part of the ongoing new drug application, or NDA, review, the U.S. Food and Drug Administration 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, 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.
Preliminary results of Study 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.
The company expects to provide results from Study to the FDA prior to the Prescription Drug User Fee Act date of August 16, 2009.
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