FREE Daily Stock Alerts From Stock-PR.com
NeurogesX, Inc. (Nasdaq:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental new drug application (sNDA) for Qutenza(NYSE:R) (capsaicin) 8% for the management of neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN). The FDA has granted Qutenza a priority six month review classification, assigning a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2012.
"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.
HIV-PN is the most common neurological complication of HIV infection. Many patients with HIV are afflicted with symptoms ranging from mild tingling to severe and excruciating pain. HIV-PN is thought to be caused by multiple factors related to HIV infection including injury of sensory neurons by HIV virus proteins, the immune system's fight against HIV and some antiretroviral drugs.
NeurogesX, Inc. is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.
More about NGSX at www.neurogesx.com
Read full article at: http://stock-pr.com/?p=20697
THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!
Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. Stock-PR.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold Stock-PR.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://stock-pr.com/disclaimer).Crown Equity Holdings Inc. (OTCPK:CRWE) is a media-advertisement and newswire company.Crown Equity Holdings Inc. (OTCPK:CRWE), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (OTCPK:CRWE) advertises for a particular client, Crown Equity Holdings Inc. (OTCPK:CRWE) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (OTCPK:CRWE), if paid in stock, can and may sell those securities during the advertising period.