NeurogesX, Inc. (NGSX) said that the U.S. Food and Drug Administration agreed to its proposed study to evaluate Qutenza in patients with post-herpetic neuralgia, or PHN, following pretreatment with an FDA-approved topical anesthetic. As part of its ongoing new drug application, or 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 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 topical anesthetic.
According to the company, 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. The endpoint of the study is the mean duration of patch application.
The 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.
For comments and feedback: editorial@rttnews.com