FDA accepts NeurogesX’s NDA for post-herpetic neuralgia treatment

NGX-4010 is a dermal high-concentration capsaicin patch designed to provide rapid, localized and sustained pain relief in patients with post-herpetic neuralgia (PHN).

The company also announced that it has proposed to market NGX-4010 under the brand name ‘Qutenza’, pending FDA approval of both the new drug application (NDA) and the proposed brand name.

The NDA, submitted to the FDA in October 2008, includes data from over 2,300 patients. The application is supported by positive results from two pivotal studies in which a single 60-minute application of Qutenza demonstrated a statistically significant reduction in pain from baseline for up to 12 weeks in patients with PHN, the company said. The most common adverse reactions associated with Qutenza were redness, pain and itching at the application site during and shortly after application.

Based on the FDA’s standard review timeline, the expected Prescription Drug User Fee Act (PDUFA) date for the potential marketing approval of Qutenza is in late 2009. In addition, the company anticipates a potential decision from the European Medicines Agency in the first half of 2009 regarding its marketing authorization application (MAA) to market Qutenza as a treatment for peripheral neuropathic pain in Europe.

Anthony DiTonno, president and CEO of NeurogesX, said: The FDA’s acceptance to review our NDA for Qutenza is a major milestone for NeurogesX as we pursue our top priority to secure marketing approvals in both the US and Europe. With both our NDA and MAA officially under regulatory review, we are one step closer to the potential launch of Qutenza and becoming a commercial enterprise.