Regulatory Plans on Track
SAN MATEO, Calif., Sept. 24 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it has responded on schedule to the European Medicines Agency's (EMEA) Day 120 questions to support the Marketing Authorization Application (MAA) for NGX-4010 in peripheral neuropathic pain.
NeurogesX' MAA for NGX-4010 in peripheral neuropathic pain was accepted for review by the EMEA in September 2007. The Day 120 questions and related responses are part of the agency's ongoing review process of the marketing application.
Anthony DiTonno, President and CEO, commented, "With the submission of our responses to the EMEA's Day 120 questions, we are pleased to reiterate that our regulatory timelines for NGX-4010 remain on track with respect to the MAA review in Europe and our plans to submit a new drug application to the FDA by year end."
About NeurogesX, Inc.
NeurogesX (Nasdaq: NGSX) is a biopharmaceutical company focused on developing and commercializing 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 NGX-4010, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions, that the Company believes offers significant advantages over other pain therapies. NeurogesX' marketing authorization application (MAA) to the European Medicines Agency (EMEA) was accepted for review in September 2007 and NeurogesX plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2008 for PHN.
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 is currently in a Phase 1 clinical trial. The objective of the development program is to determine the ability of NGX-1998 to provide protracted pain relief from a single treatment. As a liquid, NGX-1998 is expected to be suitable for areas of the skin where dermal patches may be difficult or impractical to apply, such as the hairline. The goal of the NGX 1998 program is to develop a product that has the potential to be used by a broad spectrum of the physician population. NGX-1998 was previously studied in two Phase 1 studies in healthy volunteers conducted under an exploratory investigational new drug application.
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, the expected timing of
regulatory filings with respect to NeurogesX' product candidates, including
for NGX-4010 the potential filing of an NDA; the timing of the completion
of the Phase 1 clinical trial for NGX-1998; the potential markets for
NeurogesX' product candidates and the expected benefits of NeurogesX'
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, NeurogesX' product
candidates may have unexpected adverse side effects or inadequate
therapeutic efficacy; positive results in clinical trials may not be
sufficient to obtain FDA or European regulatory approval; any regulatory
approvals which are received may be limited to certain indications;
physician or patient reluctance to use NGX-4010 or NGX-1998, if approved,
or the inability of physicians to obtain sufficient reimbursement for such
procedures; potential alternative therapies; maintaining adequate patent or
trade secret protection without violating the intellectual property rights
of others; and other difficulties or delays in, clinical development,
obtaining regulatory approval, market acceptance and commercialization of
NeurogesX' product candidates and the advantages of NeurogesX' product
candidates over other pain therapies. For further information regarding
these and other risks related to NeurogesX' business, investors should
consult NeurogesX' filings with the Securities and Exchange Commission.
Chief Financial Officer
The Ruth Group
Stephanie Carrington / Sara Ephraim (investors)
(646) 536-7017 / 7002
Jason Rando (media)
|SOURCE NeurogesX, Inc.|
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