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Trans-Capsaicin Dermal Patch Study Results Demonstrate Pain Reduction in HIV-Associated Sensory Neuropathy

SAN CARLOS, Calif.--(BUSINESS WIRE)--May 18, 2005--NeurogesX Inc., a privately held specialty pharmaceutical company, today announced positive results from a multi-center, randomized, double blind, controlled Phase 3 trial in 307 patients suffering from painful HIV-associated sensory neuropathy (HIV-AN). The study met its pre-specified primary endpoint with patients reporting statistically significant pain reduction over a 12-week period (p less than 0.005 when compared with control) following a single application of NGX-4010, NeurogesX's novel high-concentration trans-capsaicin dermal patch.

"This is a potential breakthrough for patients suffering from painful HIV-associated sensory neuropathy, a frequent yet difficult to manage neurological complication of HIV infection for which there are currently no approved therapies in the United States," said David Simpson, M.D., Professor of Neurology at Mount Sinai School of Medicine in New York and lead academic investigator in the NeurogesX study. "There is a great need for an effective product that controls pain without introducing safety or drug interaction concerns, particularly for HIV patients who are already taking numerous medications to manage their primary disease. We anticipate presenting the full study findings in a scientific presentation and a manuscript later in the year."

"We believe this study validates the science underlying the unique mechanism of action of our core technology," said Anthony A. DiTonno, NeurogesX President and CEO. "Capsaicin is a TRPV1 agonist and the selective expression of TRPV1 on pain-producing nerve fibers in the skin, coupled with our patented delivery system, allows us to target the peripheral pain signal that often drives the neuropathic pain process."

NeurogesX plans to initiate a second pivotal Phase 3 trial with NGX-4010 for HIV-AN later this year. The company has been granted fast track status as well as orphan drug designation for NGX-4010 in this indication by the U.S. Food and Drug Administration (FDA).

"We now anticipate our development plan to include filing a new drug application (NDA) with data from our HIV-AN program as well as our postherpetic neuralgia program in mid-2007. Additionally, we expect to file an application for European marketing approval in the second half of 2006," said Mr. DiTonno. "There is a very large unmet medical need in the treatment of neuropathic pain and this is an important step toward a non-centrally acting option for physicians and patients."

About NGX-4010
NGX-4010 is a topical, physician administered patch containing a high concentration of trans-capsaicin, a synthetic form of the naturally occurring capsaicin and the ingredient that makes chili peppers hot. The patch is designed to act peripherally, or in the skin, where the pain frequently originates, 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. Due to the novel patch delivery system and dermal site of action of NGX-4010, the potential for safety issues or side effects that negatively impact quality of life is expected to be low.

About HIV-Associated Neuropathy
Painful HIV-AN is the most frequent neurological complication of HIV/AIDS. Advanced HIV infection and certain HIV medications are both associated with the development of neuropathy and neuropathic pain, usually in the feet, but which can also occur in the hands. Symptoms range from mild tingling to severe and excruciating pain in response to normal activities of daily living.

Source: NeurogesX Inc.

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