Press Release
NeurogesX Announces Presentation of Positive Phase 3 Results in Painful HIV-Associated Neuropathy at CROI
San Carlos, Calif. - February 9, 2006NeurogesX, Inc., a privately held specialty pharmaceutical company, today announced that a webcast presentation of positive Phase 3 trial results in painful HIV-associated sensory neuropathy (HIV-AN) is available on the company's Web site at http://www.neurogesx.com. David Simpson, M.D., Professor of Neurology at Mount Sinai School of Medicine in New York and lead academic investigator in the NeurogesX trial, presented the results of the study at the 13th Annual Conference on Retroviruses and Opportunistic Infections (CROI). Dr. Simpson's discussion was based on an abstract titled, "Controlled Study of High-Concentration Capsaicin Patch for Painful HIV-Associated Distal Sensory Polyneuropathy."
The study evaluated the effect of a single application of NGX-4010 (Transacin™), the company's novel high-concentration trans-capsaicin dermal patch, on pain due to HIV-AN. The primary endpoint in this Phase 3 trial was achieved, demonstrating a statistically significant reduction in pain over a 12-week period (NGX-4010, -22.8% vs. control, -10.7%; p = 0.0025).
NeurogesX plans to initiate a second Phase 3 trial in HIV-AN in the first half of 2006. Transacin has been granted orphan drug and fast track status for HIV-AN by the U.S. Food and Drug Administration (FDA).
About Transacin
Transacin is a neuropathic pain treatment that is clinically administered via a dermal patch. Transacin has a profile unlike currently available neuropathic pain treatment options, which are associated with systemic side effects and inconvenient dosing regimens. The company has studied the effects of Transacin in more than 500 patients suffering from postherpetic neuralgia (PHN), more than 300 patients with HIV-AN and approximately 100 patients with painful diabetic neuropathy (PDN) with no reported significant safety issues to date. NeurogesX is currently conducting a pivotal trial with Transacin for the treatment of PHN and plans to initiate a second pivotal trial in PHN in the first half of 2006.
About NeurogesX
NeurogesX is a privately held specialty pharmaceutical company focused on the development of novel treatments for the management of neuropathic pain and improving quality of life using advanced neuroscience insights and innovative delivery technologies. The company's initial products are focused on the treatment of chronic pain in the areas of postherpetic neuralgia (PHN), painful HIV-associated sensory neuropathy (HIV-AN) and painful diabetic neuropathy (PDN). Additional information about NeurogesX can be found at www.neurogesx.com.
NeurogesX is a trademark of NeurogesX, Inc. All other trademarks and registered trademarks are those of their respective companies.
Contacts:
Anthony A. DiTonno
CEO and President
NeurogesX, Inc.
aditonno@neurogesx.com
650-508-2116
Stephen F Ghiglieri
CFO
NeurogesX, Inc.
sghiglieri@neurogesx.com
650-508-2116
Jody Cain
Lippert/Heilshorn & Associates
jcain@lhai.com
310-691-7100
Brandi Floberg
Lippert/Heilshorn & Associates
bfloberg@lhai.com
310-691-7100