NeurogesX Announces Publication of Phase 3 Data for QUTENZA (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 http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(08)70228-X/full.
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 email@example.com firstname.lastname@example.org Jason Rando (media) (646) 536-7025 email@example.com
Source: NeurogesX, Inc.
CONTACT: Stephen Ghiglieri, Chief Financial Officer of NeurogesX, Inc.,
+1-650-358-3310; or Investors, Stephanie Carrington, +1-646-536-7017,
firstname.lastname@example.org, or Sara Ephraim, +1-646-536-7002,
email@example.com, or Media, Jason Rando, +1-646-536-7025,
firstname.lastname@example.org, all of The Ruth Group, for NeurogesX, Inc.
Posted: January 2009