November 23, 2011
NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced on November 14 that the Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for Qutenza (capsaicin) for the management of neuropathic pain caused by HIV-associated peripheral neuropathy (HIV-PN). The FDA has granted Qutenza a priority six month review classification.
"The FDA's filing and priority review of our sNDA for Qutenza in HIV-PN is a significant achievement for NeurogesX as we seek to expand our pain management franchise," said Anthony DiTonno, President and CEO of NeurogesX. "This takes us another step forward in our effort to provide lasting relief from one of the most challenging chronic pain conditions. We look forward to our continued discussion with the FDA during the review of this application."
The Qutenza sNDA seeks approval for a 30-minute application for the treatment of neuropathic pain associated with HIV-PN. Qutenza is currently FDA approved as a 60-minute application for the management of neuropathic pain associated with postherpetic neuralgia (PHN). If approved, the company believes that Qutenza would be the first and only product approved to treat HIV-PN in the United States.