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.
03.08.2012; Kavyanjali Kaushik
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.
Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)