SAN MATEO, Calif., June 10 /PRNewswire-FirstCall/ - NeurogesX, Inc. , 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, NGX-4010, in the journal Neurology. The paper, titled, “Controlled Trial in High-Concentration Capsaicin Patch for Treatment of Painful HIV Neuropathy,” will appear in the June 10, 2008 edition. The topline results from the C107 study were presented in February 2006 by study investigator and lead author, Dr. David Simpson, Professor of Neurology and Director of Clinical Neurophysiology Laboratories and Neuro-AIDS Program at The Mount Sinai Medical Center.
The Phase 3 trial was a randomized, double blind, multicenter, controlled study involving 307 patients with painful HIV-associated distal sensory polyneuropathy (HIV-DSP) receiving a single application of NGX-4010, a high-concentration capsaicin patch. In this trial, the primary endpoint was achieved with a statistically significant reduction in pain over a 12-week period. The NGX-4010 application was well tolerated with the most common side effects being transient application site reactions.
About NeurogesX, Inc.
NeurogesX 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.
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 benefits of NeurogesX’ lead product candidate, NGX-4010. 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 candidate 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; physician or patient reluctance to use NGX-4010, 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 NGX-4010 and the advantages of NGX-4010 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.
CONTACT: Stephen Ghiglieri, NeurogesX, +1-650-358-3310,
sghiglieri@neurogesx.com; Investors, Stephanie Carrington, +1-646-536-7017,
scarrington@theruthgroup.com, or Media, Jason Rando, +1-646-536-7025,
jrando@theruthgroup.com, both of The Ruth Group for NeurogesX, Inc.
