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Title: Capsaicin Patch Approved for Peripheral Neuropathic Pain in Non-Diabetic Adults

"Capsaicin Patch Approved for Peripheral Neuropathic Pain in Non-Diabetic Adults"

NEW YORK -- May 21, 2009 -- The European Commission has formally granted marketing authorisation of capsaicin 179 mg cutaneous patch (Qutenza) for the treatment of peripheral neuropathic pain in patients without diabetes, either alone or in combination with other medicinal products for pain. The approval of follows a positive opinion recommending approval from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on March 19. The cutaneous patch is designed to locally deliver a high-concentration (8%) of capsaicin and to provide sustained relief from peripheral neuropathic pain. Following application to the painful areas on the skin, the patch is allowed to remain in place for 30 minutes for the feet and 60 minutes for other locations. The capsaicin patch is not indicated for adults who have diabetes as there is only limited experience with the drug in patients with Painful Diabetic Neuropathy (PDN), and repeated treatments with capsaicin patch in patients with PDN have not been studied. SOURCE: NeurogesX, Inc.

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