NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic... ( Trial Meets Primary and...)

NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic Neuralgia

Date:9/4/2007

Trial Meets Primary and All Secondary Endpoints

San Carlos, Calif., Sept. 4 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing novel pain management therapies, today announced positive top-line results from its second pivotal study of NGX-4010, the Company's dermal patch containing the TRPV1 agonist -- synthetic capsaicin -- in patients with postherpetic neuralgia (PHN). The study, a multi-center, double-blind, controlled Phase 3 trial, met its pre-specified primary endpoint: the reduction in pain from baseline to study weeks 2-8 (p=0.01). The study demonstrated a 32% reduction in pain from baseline from a single 60-minute application of NGX-4010 as compared to a 24% reduction in pain in the control group. Additionally, significant results were achieved for study weeks 2-12 (p<0.02), a secondary endpoint. All other secondary endpoints, including 30% and 50% responder analyses, were also met.

The study evaluated 416 patients enrolled at study sites in both the United States and Canada. Similar in design to the Company's previous, successfully completed C116 Phase 3 trial, the C117 trial evaluated the effect of a single, 60-minute treatment with NGX-4010 compared to a control patch containing a low concentration of NGX-4010's active ingredient. The treatment was administered by a study physician during an in-office procedure. After one hour, the patch was removed and the patient's response to treatment was evaluated daily using an 11-point numeric pain rating scale during the subsequent 12-week study period.

The initial safety analysis of the clinical trial results was consistent with the safety profile observed in previous Phase 3 stu
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NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic...( Trial Meets Primary and...),Health