FDA Declines to Approve NeurogesX Patch for HIV Pain

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.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.

TOGETHER WE REMAIN STRONG!