NeurogesX To Hold Conference Call To Discuss FDA Approval Of Qutenza(TM) (capsaicin) 8% Patch For Treatment Of Postherpetic Neuralgia (PHN)

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 18 Nov 2009 - 3:00 PDT

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NeurogesX, Inc. (Nasdaq: NGSX) announces that it will hold a conference call at 8:30a.m. ET (5:30a.m. PT) to discuss the U.S. Food and Drug Administration (FDA) approval of Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles.

About Qutenza

Qutenza(TM) (capsaicin) 8% patch is a dermal delivery system that contains a prescription strength of capsaicin approved in the United States for the management of PHN. Qutenza is designed to reduce the pain associated with PHN after a single one hour administration. The capsaicin in Qutenza is a synthetic equivalent of a naturally occurring compound found in chili peppers. Qutenza has also been approved in the European Union.

About NeurogesX, Inc.

NeurogesX 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 and is now poised to bring its lead product to patients and physicians. In addition, we continue to apply our knowledge and expertise in the development of other novel treatments for pain.

Our lead product, Qutenza(TM) (capsaicin) 8% patch, is a dermal delivery system containing a prescription strength of capsaicin that is currently approved in the United States and the European Union. Qutenza is expected to be launched by NeurogesX in United States in the first half of 2010. In Europe, Qutenza will be marketed by Astellas Pharma Europe Ltd., (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc.

NeurogesX's 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.

NeurogesX's 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.

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 of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to: statements about the safety and efficacy of Qutenza(TM); the timing of launch of Qutenza; and development activities for NGX-1998 and other product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: any regulatory approvals which are received may be limited to certain indications; Qutenza and NeurogesX's other product candidates may have unexpected adverse side effects; difficulties or delays in the launch and commercialization of Qutenza; and the outcomes of any submissions to the FDA for NeurogesX's products and product candidates. For further information regarding these and other risks related to NeurogesX's business, investors should consult NeurogesX's filings with the Securities and Exchange Commission.

Source: NeurogesX

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