Press Release
NeurogesX Completes Enrollment in Pivotal Phase 3 Postherpetic Neuralgia Trial
San Carlos, Calif. - June 13, 2006NeurogesX, Inc., a privately held specialty pharmaceutical company, today announced that it has completed enrollment in its 400-patient Phase 3 trial of its investigational drug Transacin™ (NGX-4010) in patients suffering from postherpetic neuralgia (PHN). Transacin is NeurogesX's novel high-concentration trans-capsaicin dermal patch. The randomized, double blind, controlled study is being conducted at more than 50 U.S. clinical sites. The company expects final data from this study to be available in the fourth quarter of this year.
"We believe that Transacin could prove to be an effective treatment option for patients with neuropathic pain conditions such as PHN," said Anthony A. DiTonno, NeurogesX President and CEO. "Our previous PHN study results, which include data from nearly 500 patients in three studies, suggest a clinically meaningful therapeutic effect after a single, one-hour administration of the Transacin patch. We are optimistic that this study will result in a significant reduction in reported pain and further validate that Transacin can provide meaningful relief in PHN without the considerable side effects of existing PHN treatments."
"We expect this PHN study, together with our previously reported, positive Phase 3 study in HIV-associated sensory neuropathy (HIV-AN), will provide the basis of a marketing application for a broad label in neuropathic pain in Europe early next year," he added.
A second, confirmatory Phase 3 PHN trial is currently being initiated and will be conducted in both the U.S. and Canada.
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 acting on the central nervous system that 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. In a Phase 3 study in HIV-associated sensory neuropathy (HIV-AN), Transacin showed statistically significant reductions in pain (p=0.0025) compared to a low concentration comparator. This study result was announced in May 2005. The company expects to begin patient enrollment in a multinational study in HIV-AN in mid 2006.
About Postherpetic Neuralgia
Postherpetic neuralgia is chronic, burning pain that develops in about 20 percent of patients after the herpes zoster rash (shingles) heals. The pain is often refractory to treatment and may persist for years. As the population ages, the incidence of postherpetic neuralgia is expected to rise, since older people are more susceptible to shingles. In addition, people infected with HIV develop shingles up to 15 times more frequently than the general population.
About NeurogesX
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 postherpetic neuralgia (PHN), painful HIV-associated sensory 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. near the end of 2007. Additional information about NeurogesX can be found at www.neurogesx.com.
NeurogesX is a trademark of NeurogesX, Inc.
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