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FDA Panel: Qutenza Pain Patch for Neuropathy Not Ready for Approval

A U.S. Food and Drug Administration advisory committee voted unanimously against recommending the approval of a novel patch applied to the soles of the feet to remedy pain associated with neuropathy in people living with HIV. Though the patch is commercially available for the treatment of shingles-related neuropathy pain, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee’s review of two clinical trials of the Qutenza capsaicin patch involving HIV-positive volunteers did not find “substantial evidence of effectiveness.”

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