Navigation Links
NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by The Lancet Neurology

SAN MATEO, Calif., Jan. 12 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today the publication of Phase 3 data of its lead product candidate, Qutenza (NGX-4010), for the treatment of postherpetic neuralgia (PHN) in the December 2008 print edition of The Lancet Neurology. The article is also available through Lancet Online at

The U.S. Food and Drug Administration (FDA) recently accepted for filing the Company's new drug application (NDA) requesting approval of Qutenza for the management of pain associated with PHN. A marketing authorization application (MAA) for Qutenza is also under review by the European Medicines Agency (EMEA) for the management of peripheral neuropathic pain.

The paper in The Lancet Neurology titled, "NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, doubleblind study," presented results from NeurogesX' pivotal Phase 3 study (study C116). The initial results from this study were announced in October 2006.

The study randomized 402 patients between 18-90 years of age to receive either one 60-minute application of Qutenza (n=206) or a low-concentration capsaicin control patch (n=196). Patients were required to have had PHN for at least six months prior to enrollment, with an average baseline pain rating scale (NPRS) score ranging from three to nine. The study successfully met its primary endpoint by showing a significantly greater percentage reduction in NPRS score from Baseline to Weeks two through eight, compared with patients who received the control patch. Reduction in pain during Weeks two through twelve was also significantly greater in patients treated with Qutenza. Qutenza was generally well tolerated. The most common adverse effects were related to local, application site reactions and treatment-associated pain.

Anthony DiTonno, President and CEO, commented, "Current PHN treatment options have limitations that we believe present an opportunity for Qutenza to address. In addition to the potential for a long duration of effect, Qutenza acts locally, at the pain site, as opposed to through the central nervous system, and has the potential to manage pain resulting from PHN without causing some of the common side effects associated with currently available systemic treatment options. With both our NDA and MAA currently under review, we look forward to regulatory decisions on these applications and the potential for subsequent commercial launches of Qutenza in both the United States and European Union."

The first author of the publication, Miroslav Backonja M.D., Professor of Neurology, Anesthesiology and Rehabilitation Medicine at the University of Wisconsin School of Medicine, stated, "The results from the Phase 3 C116 study of Qutenza in patients with PHN showed that a single 60-minute application of Qutenza has the potential to provide targeted pain management for up to 12 weeks. I am very glad that Qutenza has the potential upon approval to offer our patients a significant improvement to the current treatment options for PHN."

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 Qutenza, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions, that the Company believes offers significant advantages over other pain therapies. A NDA for Qutenza seeking approval for the management of pain due to PHN was submitted in October, 2008 and has been accepted for review by the U.S. FDA and an MAA for Qutenza seeking approval for peripheral neuropathic pain is currently under review by the European Medicines Agency (EMEA).

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 Phase 1 development.

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 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 Qutenza in the European Union and the NDA for Qutenza for PHN with the FDA, including the potential PDUFA date for the NDA; the potential markets for NeurogesX' product candidates; the expected benefits of NeurogesX' product candidates and its plans with regard to seeking potential development partners for its early-stage product pipeline. 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 offer more limited indications than anticipated; physician or patient reluctance to use Qutenza 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

    Jason Rando (media)
    (646) 536-7025

SOURCE NeurogesX, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. NeurogesX Initiates Dosing in Phase 1 Clinical Trial for NGX-1998 Capsaicin Liquid Formulation
2. NeurogesX Announces Publication of NGX-4010 Phase 3 HIV-Neuropathy Study Results in Neurology
3. NeurogesX Announces Preliminary Results from Second Phase 3 Clinical Trial in HIV-DSP
4. NeurogesX Completes Enrollment in Confirmatory Phase 3 Clinical Trial for Painful HIV Distal Sensory Polyneuropathy
5. NeurogesX Completes Enrollment in Confirmatory Phase 3 Clinical Trial for Painful HIV Distal Sensory Polyneuropathy
6. NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic Neuralgia
7. Pulmo BioTech Inc. Announces Dual Listing on Frankfurt Borse
8. Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare Conference
9. Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
10. ProUroCare Medical Inc. Announces Pricing of Equity Offering
11. Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function
Post Your Comments:
(Date:11/24/2015)... 25, 2015 WuXi PharmaTech (Cayman) Inc. ("WuXi" ... open-access R&D capability and technology platform company serving the ... China and the ... extraordinary general meeting of shareholders held today, the Company,s ... and approve the previously announced agreement and plan of ...
(Date:11/24/2015)... 2015  Array BioPharma Inc. (Nasdaq: ARRY ... Ron Squarer , will present at the ... The public is welcome to participate in the ... website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  , Ron Squarer, ... p.m. Eastern Time Webcast: , ...
(Date:11/24/2015)... , Nueva York , ... Biomedical Devices (ABD), fabricante del Avery Breathing Pacemaker ... Anders Jonzon , MD; Ph.D. como consultor clínico. ...   --> Foto - ... --> El doctor Jonzon es un fisiólogo ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... SCOTTSDALE, AZ) - ... surgeon specializing in both surgical and non-surgical treatments, announced the expansion of his ... Facial Plastic Surgery. , Highly trained and nationally recognized for his natural ...
(Date:11/25/2015)... D.C. (PRWEB) , ... November 25, 2015 , ... Today, ... fatalities on our nation’s roadways has dropped below 10,000 for the first time since ... 10,076 in 2013. , According to data released by the National Highway Traffic Safety ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely combination of ... a way for homeless people to have a more dignified and comfortable night’s ... whereby they are repurposing plastic bags into sleeping mats for the homeless. ...
(Date:11/25/2015)... ... November 25, 2015 , ... Bunion ... in an early celebration of the early holiday shopping season. Starting Wednesday November ... (normally $33.95 ea). Black Friday promotional pricing is in addition to any automatic ...
(Date:11/24/2015)... ... 2015 , ... Young patients with a wide variety of dental needs can ... S. Lele, who are pediatric dentists in Tucson, AZ . Unlike traditional treatment ... system causes minimal discomfort and bleeding to the patient during treatment and the following ...
Breaking Medicine News(10 mins):