Pain Patch for HIV Neuropathy Voted Down
“By a vote of 12-0, an FDA advisory panel said a capsaicin skin patch did not relieve neuropathic pain from HIV.
The dermal patch (Qutenza), which contains a synthetic form of capsaicin — the ingredient that makes chili peppers hot — is already approved to treat pain associated with shingles. NeurogesX, which markets the patch, is seeking to expand the marketing indication to include treatment for pain associated with HIV neuropathy.
The Anesthetic and Analgesic Drug Products Advisory Committee concluded that the benefits of the 8% capsaicin patch did not outweigh its risks as a treatment for HIV-associated peripheral neuropathy. The patient representative on the panel abstained from voting.
All panelists expressed major disappointment in voting down the drug — which was poised to be the first approved treatment of a condition that affects up to 40% of patients with HIV.
But the panel members concluded that the available data did not support an approval and many panel members blamed a poor study design for the lack of persuasive data.
The FDA is not required to follow the advice of its advisory committees, but it often does.”
