Navigation Links
NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)
Date:10/22/2008

Marketing Application Submitted on Schedule

SAN MATEO, Calif., Oct. 22 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its investigational product candidate, NGX-4010, for the management of pain due to postherpetic neuralgia (PHN). NeurogesX anticipates that the application, which is subject to acceptance by the FDA, will be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2009.

NGX-4010, the Company's lead product candidate, is a dermal high-concentration capsaicin patch. The NDA submission is supported by two pivotal studies of NGX-4010 in patients with PHN. The results of these clinical trials show a statistically significant reduction in pain from baseline for up to 12 weeks after a single 60-minute application of the dermal patch. In these studies, NGX-4010 could be administered either as a monotherapy or in combination with other systemic neuropathic pain medications. The most common adverse reactions associated with NGX-4010 were redness, pain, and itching at the application site during and shortly after application. The NDA clinical package includes data on over 2300 patients with neuropathic pain.

Anthony DiTonno, President and CEO, commented, "Our top priority is to secure marketing approval of NGX-4010 in both the United States and Europe. With the submission of our NDA and the ongoing review of our Marketing Authorization Application in the European Union, from which we anticipate a decision in the first half of 2009, we look forward with excitement to the potential for approval and subsequent commercial launch of NGX-4010 in both the United States and the European Union."

PHN is a chronic painful condition that develops in approximately 20% of patients following a herpes zoster (shingles) outbreak. An estimated one million people in the United States develop shingles annually. Current treatments for PHN include antidepressants, anticonvulsants, topical agents and opioid analgesics.

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 submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in October, 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 for NGX-1998 is to determine its ability 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. NGX-1998 is being developed with the goal of it becoming 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 decisions with respect to the MAA for NGX-4010 in the European Union and the NDA for NGX-4010 for PHN with the FDA, including the potential PDUFA date for the NDA; 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.

NeurogesX, Inc.

Stephen Ghiglieri

Chief Financial Officer

(650) 358-3310

The Ruth Group

Stephanie Carrington / Sara Ephraim (investors)

(646) 536-7017 / 7002

scarrington@theruthgroup.com

sephraim@theruthgroup.com

Jason Rando (media)

(646) 536-7025

jrando@theruthgroup.com


'/>"/>
SOURCE NeurogesX, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. NeurogesX Responds to EMEAs Day 120 Questions
2. NeurogesX to Present at Morgan Stanley Global Healthcare Unplugged Conference
3. NeurogesX Reports Second Quarter 2008 Results
4. NeurogesX to Report Second Quarter 2008 Financial Results
5. NeurogesX Opens Investigational New Drug Application for Capsaicin Liquid Formulation NGX-1998
6. NeurogesX to Present at the Rodman & Renshaw 5th Annual Global Healthcare Conference
7. NeurogesX Reports First Quarter 2008 Results
8. NeurogesX to Report First Quarter 2008 Financial Results
9. NeurogesX to Present at the 2008 Morgan Stanley Global Healthcare Unplugged Conference
10. NeurogesX to Report Fourth Quarter and Year-End 2007 Financial Results
11. NeurogesX to Present at Roth 2008 OC Growth Stock Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers and ... and the 6000i models are higher end machines that use the more unconventional z-dimension ... light beam from the bottom of the cuvette holder. , FireflySci has developed ...
(Date:6/23/2016)... , June 23, 2016 /PRNewswire/ - FACIT has ... Ontario biotechnology company, Propellon Therapeutics Inc. ... and commercialization of a portfolio of first-in-class WDR5 ... targets such as WDR5 represent an exciting class ... in precision medicine for cancer patients. Substantial advances ...
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge (BDC), ... new ways to harness living systems and biotechnology, announced ... (MoMA) in New York City . ... participating students, showcased projects at MoMA,s Celeste Bartos Theater ... Antonelli , MoMA,s senior curator of architecture and design, ...
(Date:6/23/2016)... LOUISVILLE, Ky. , June 23, 2016 /PRNewswire/ ... from two Phase 1 clinical trials of its ... double-blind, placebo-controlled, single and multiple ascending dose studies ... and pharmacodynamics (PD) of subcutaneous injection in healthy ... APL-2 subcutaneously (SC) either as a single dose ...
Breaking Biology Technology:
(Date:5/12/2016)... May 12, 2016 WearablesResearch.com , a ... the overview results from the Q1 wave of its ... wave was consumers, receptivity to a program where they ... a health insurance company. "We were surprised ... says Michael LaColla , CEO of Troubadour Research, ...
(Date:4/28/2016)... April 28, 2016 First quarter 2016:   ... 966% compared with the first quarter of 2015 The ... 589.1 M (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) ... guidance is unchanged, SEK 7,000-8,500 M. The operating margin ...
(Date:4/15/2016)...  A new partnership announced today will help ... in a fraction of the time it takes ... life insurance policies to consumers without requiring inconvenient ... Diagnostics, rapid testing (A1C, Cotinine and HIV) and ... weight, pulse, BMI, and activity data) available at ...
Breaking Biology News(10 mins):