20-Patient Study to Evaluate FDA-Approved Topical Anesthetic Pretreatment
SAN MATEO, Calif., June 10 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX) announced today that the U.S. Food and Drug Administration (FDA) agreed to its proposed study to evaluate Qutenza(TM) in patients with post-herpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. As part of its ongoing new drug application (NDA) review, the FDA wants to determine whether pretreatment with an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program.
The FDA is currently reviewing the NDA for Qutenza in PHN, which has a Prescription-Drug User Fee Act (PDUFA) date of August 16, 2009. The marketing application is supported by clinical studies of Qutenza which was applied after a 60-minute pretreatment with a commercially available but not a formally FDA approved over the counter (OTC) topical anesthetic.
To fulfill the agency's request, the study protocol involves enrolling approximately 20 patients with PHN to receive the Qutenza patch application after a 60-minute pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine) The endpoint of the study is the mean duration of patch application. Previous clinical trial experience using the OTC topical anesthetic indicated that most patients tolerate the full 60-minute procedure. This study is designed to determine whether a similar tolerability profile can be accomplished with an FDA approved topical anesthetic. Patient safety will also be monitored for seven days following treatment. The Company has already commenced screening patients in this study.
Based on the expected short-term nature of the study, NeurogesX could potentially
|SOURCE NeurogesX, Inc.|
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