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U.S. News

FDA Declines to Approve NeurogesX Patch for HIV Pain

March 16, 2012

The Food and Drug Administration recently declined to approve a patch intended to relieve neuropathic pain in people with HIV. The decision follows an FDA advisory panel's 12-0 vote in early February against approving Qutenza, citing lack of substantial evidence of effectiveness for the patch, which is based on the chili-pepper agent capsaicin. To obtain approval, patch-maker NeurogesX Inc. would have to submit additional data from an adequate, well-controlled trial, FDA said. NeurogesX said it does not anticipate conducting further clinical studies on the patch, but that it will work with FDA to understand the criteria for approval. In the meantime, it will focus on developing NGX-1998, a capsaicin-based liquid formulation. The patch is already approved for shingles-related pain.

Back to other news for March 2012

Adapted from:
Reuters
03.08.2012; Kavyanjali Kaushik


  
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This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
See Also
More on the FDA Drug Approval Process and Other Regulatory Issues

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