ng novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate Qutenza, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. Qutenza will be marketed in the European Union and certain countries in Eastern Europe, the Middle East and Africa, by Astellas Pharma Europe, Ltd. In the United States, NeurogesX submitted a new drug application (NDA) for PHN to the U.S. Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and has been given an extended Prescription Drug User Fee Act (PDUFA) date of November 16, 2009.
NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently planning the design and timing of this program.
NeurogesX' early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection
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Page: 1 2 3 4 5 Related biology technology :1.
NeurogesX Reports Second Quarter 2009 Results2.
NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application3.
NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results4.
NeurogesX Added to Russell 3000 Index5.
NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)6.
NeurogesX to Present at Needham Life Sciences Conference7.
NeurogesX Receives European Commission Approval for Qutenza(TM)8.
NeurogesX Reports First Quarter 2009 Results9.
NeurogesX to Hold Conference Call to Discuss First Quarter 2009 Financial Results10.
NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting11.
NeurogesX to Hold Conference Call to Discuss Fourth Quarter and Year-End 2008 Financial Results and European Regulatory Update