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NeurogesX pain patch fails a late-stage trial

NeurogesX says its dermal patch pain therapy--NGX-4010--failed a late stage study. Researchers say that patients getting the NGX-4010 patch achieved a 29.5 percent reduction in pain from baseline over weeks 2 to 12 compared to a 24.6 percent reduction for the control group--not a statistically significant improvement. NeurogesX blamed a big placebo response for the trial failure.

"We observed responses in the NGX-4010 treatment arms consistent with what we have seen in multiple previous studies," CMO Dr. Jeffrey Tobias commented. "However, the response in the 60-minute control group was greater than anticipated. We are encouraged that the safety profile of this study supports the lack of any observed major safety issues associated with NGX-4010 and that treatment with NGX-4010 was well tolerated. Since these results are preliminary, we have more analysis to carry out on this data. However, our initial evaluation of the data suggests that the NGX-4010 treatment arms behaved similarly to our other studies and there was a trend in favor of treatment. We will continue to evaluate whether the cumulative clinical data from our clinical studies may be able to support evidence of efficacy in HIV-DSP."

- check out the release

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More stories about Phase III   Drug Safety   safety profile   HIV/AIDS   NeurogesX  

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