NeurogesX Provides Regulatory Update for Qutenza

NeurogesX has announced that FDA agreed to its proposed study to evaluate Qutenza 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.