Healthcare Industry News: shingles
News Release - October 18, 2006
NeurogesX Phase 3 Study in Post-Herpetic Neuralgia Meets Primary EndpointEnables Near-Term European Filing
SAN CARLOS, Calif.--(HSMN NewsFeed)--NeurogesX Inc., a privately held specialty pharmaceutical company, today announced positive results from a multi-center, double-blind, controlled Phase 3 trial of Transacin(TM) (NGX-4010), the Company's novel high-concentration trans-capsaicin dermal patch, in patients with post-herpetic neuralgia (PHN). The study met its pre-specified primary endpoint with patients reporting statistically significant pain reduction after a single one-hour application of Transacin, (p=0.001). A significant reduction in pain was noted during the first week following treatment (p=0.04) and was maintained throughout the 12-week study period. At 12 weeks, more than one-half of all subjects treated with Transacin reported improvement in their condition, as measured by the Patient Global Impression of Change scale.
The study was conducted at 53 clinical sites in the U.S. Four-hundred and two patients suffering from PHN were randomized to a single, one-hour treatment with Transacin or to a matching, low-concentration capsaicin control patch. Study subjects were then followed for 12 weeks. Pain was recorded daily by study subjects using the Numeric Pain Rating Scale of 0 (no pain) to 10 (worst possible pain).
"Transacin has the potential to provide an important therapeutic alternative to patients suffering from post-herpetic neuralgia, a frequent, yet difficult-to-manage neuropathic pain condition that affects one in five shingles patients," said Misha-Miroslav Backonja, M.D., an investigator in the study and Director of Research and Education of the University of Wisconsin Pain Treatment Center in Madison, Wisconsin. "There is a great need for new treatments that can provide relief to patients with this painful condition."
"There is a very large unmet medical need in the treatment of neuropathic pain, and this is an important step toward providing an effective, peripherally acting treatment option," stated Jeffrey Tobias, M.D., Chief Medical Officer at NeurogesX. "We are continuing to analyze the study results and anticipate presenting the findings at a scientific conference early next year."
"This study is significant validation for Transacin and for NeurogesX, and holds promise for many long-suffering patients with neuropathic pain. We believe that a peripherally acting therapy without the traditional side effects experienced in current therapies will be well received both by physicians and their patients," said Anthony A. DiTonno, NeurogesX President and CEO. "These data, combined with our previously reported positive Phase 3 results with Transacin in painful HIV-associated neuropathy (HIV-AN), will form the basis of a Marketing Authorization Application for European Union regulatory approval in the first half of 2007."
The Company's current Transacin development plan includes filing a New Drug Application (NDA) with the U.S. Food and Drug Administration including data from its PHN and HIV-AN programs in mid-2008. To provide the required data for the NDA, NeurogesX is currently enrolling patients in two confirmatory Phase 3 studies, one in PHN at sites in the U.S. and Canada, and one in HIV-AN at sites in the U.S., Canada, the United Kingdom and Australia.
Additional information about NeurogesX's Phase 3 studies is available at http://www.clinicaltrials.gov/ct/show/NCT00321672?order=6 and at http://clinicaltrials.gov/ct/show/NCT00300222?order=1.
About Transacin (NGX-4010)
Transacin is a topical, physician-administered patch containing a high concentration of trans-capsaicin, a synthetic form of the naturally occurring TRPV1 agonist capsaicin. Unlike current treatment approaches for neuropathic pain that include opioids and other agents - which act on the central nervous system and can cause drowsiness or other systemic side effects - the patch is designed to act peripherally in the skin, where the pain frequently originates. Due to the novel patch delivery system and dermal site of action of Transacin, the potential for safety issues or side effects that negatively impact quality of life is expected to be low.
NeurogesX is a privately held specialty pharmaceutical company focused on the development of novel treatments for the management of neuropathic pain. The Company's initial products are focused on the treatment of chronic pain in the areas of post-herpetic neuralgia (PHN), painful HIV-associated neuropathy (HIV-AN) and painful diabetic neuropathy (PDN). NeurogesX intends to file for marketing approval in Europe in the first half of 2007 and plans to file an NDA in the U.S. in 2008. Additional information about NeurogesX can be found at www.neurogesx.com.
NeurogesX is a trademark of NeurogesX, Inc.
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