Business Wire - June 15, 2005
"Our 500-patient Phase 2 program gave us a better understanding of how PHN patients respond to NGX-4010. Our Phase 3 clinical protocol reflects key insights gained from our Phase 2 effort," said Anthony DiTonno, NeurogesX President and CEO. "We are confident that NGX-4010 has the potential to show a clinically meaningful drug effect. We expect to complete enrollment in our Phase 3 study in the fourth quarter of this year, and to launch a second confirmatory Phase 3 trial with NGX-4010 in PHN later this year. With this aggressive timetable, we continue to anticipate filing for marketing approval in Europe in the second half of 2006 and in the U.S. in the second quarter of 2007.
"One-half of the PHN patients in the Phase 3 study will be assigned to receive NGX-4010 for 60 minutes. The other half of the study participants will receive a control patch containing a very low concentration of capsaicin, also for 60 minutes. Assignments will be randomized and the physician and patients will be blinded to which type of patch is received. Following this single-treatment, patients will record their pain scores daily in personal diaries using a scale of 0 (no pain) to 10 (worst possible pain). The primary endpoint of this study is percent change in average pain level from baseline to weeks two to eight.
"Postherpetic neuralgia, which is chronic pain persisting after a shingles outbreak, is a debilitating disease that represents a large unmet medical need," said John Jermano, RN, MPH, NeurogesX Director of Clinical Research. "NGX-4010 may prove to have significant advantages over oral PHN treatments that have considerable side effects such as drowsiness or constipation.
"Last month, NeurogesX announced positive Phase 3 results for NGX-4010 in painful HIV-associated sensory neuropathy (HIV-AN). The company has been granted fast track status as well as orphan drug designation for NGX-4010 in HIV-AN by the U.S. Food and Drug Administration (FDA). NeurogesX also recently completed an open label Phase 2 trial involving 92 patients with painful diabetic neuropathy (PDN). The pain reduction in the PDN patients was similar to findings in the other peripheral neuropathic pain conditions studied to date.
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 Postherpetic Neuralgia
Postherpetic neuralgia is chronic, burning pain that develops in about 20 percent of patients after healing from herpes zoster rash (shingles). 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 Phase 2 PHN Program
NeurogesX's Phase 2 PHN program comprised a series of randomized, controlled trials involving approximately 500 patients conducted over the course of two years. Key findings of the NGX-4010 Phase 2 program included consistent efficacy and dose establishment with minimal clinically significant safety issues. The Phase 2 studies varied in the number of patients studied, patch application times, randomization schemes and duration of follow up. The common primary endpoint in all studies was the percent change in average pain level from baseline to weeks two to eight, based on patients' diary scores for "average pain in the past 24 hours." Data from these studies were used as the basis to design the Phase 3 protocol.
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 .
CONTACT: Company Contact:
NeurogesX, Inc.
Anthony A. DiTonno, 650-508-2116
aditonno@neurogesx.com
or
Media Contact:
Lippert/Heilshorn & Associates
Mark Stuart, 310-691-7116
mstuart@lhai.com
SOURCE: NeurogesX, Inc.
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