NeurogesX Receives Qutenza®-Specific J-Code From Centers for Medicare and Medicaid Serv... (being marketed by Astellas Pharma Europe...)

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NeurogesX Receives Qutenza®-Specific J-Code From Centers for Medicare and Medicaid Services (CMS)

Date:11/19/2010

being marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The Company is currently preparing to submit a supplemental new drug application (sNDA) to expand the U.S. label for Qutenza for the management of pain due to HIV-associated neuropathy (HIV-AN) also known as HIV-distal sensory neuropathy (HIV-DSP).

The Company's 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 such as PHN. NGX-1998 has completed three Phase 1 studies and patient dosing is underway in a Phase 2 clinical trial in PHN patients.

The Company's early-stage pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated certain of these compounds in vitro and in vivo.

Safe Harbor StatementThis 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 of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to: statements regarding the date that the new J-code is expected to become effective and the benefits of such code for potential users and sales and marketing efforts for NeurogesX; and the potential submission to the U.S. Food and Drug Administration of a supplemental new drug application for label expansion of Qutenza. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not lim
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SOURCE NeurogesX, Inc.
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Related medicine technology :

1. NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic Neuralgia
2. NeurogesX Completes Enrollment in Confirmatory Phase 3 Clinical Trial for Painful HIV Distal Sensory Polyneuropathy
3. NeurogesX Completes Enrollment in Confirmatory Phase 3 Clinical Trial for Painful HIV Distal Sensory Polyneuropathy
4. NeurogesX Announces Preliminary Results from Second Phase 3 Clinical Trial in HIV-DSP
5. NeurogesX Announces Publication of NGX-4010 Phase 3 HIV-Neuropathy Study Results in Neurology
6. NeurogesX Initiates Dosing in Phase 1 Clinical Trial for NGX-1998 Capsaicin Liquid Formulation
7. NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by The Lancet Neurology
8. NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
9. NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study
10. NeurogesX to Present at JMP Securities Healthcare Focus Conference
11. NeurogesX to Hold Conference Call to Discuss Third Quarter 2009 Financial Results

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