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| |  Ciclopirox, Topical Treatment For Nail Fungus, Approved By FDA WASHINGTON, DC -- December 17, 1999 -- The Food and Drug Administration today announced the approval of Penlac Nail Lacquer (ciclopirox) Topical Solution 8%, the first topical treatment approved in the United States for the treatment of fingernail and toenail fungus. Ciclopirox is a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, a type of fungus that grows on the skin, hair, and nails.
Simple daily activities, such as walking, can cause discomfort and pain for individuals with nail fungus disease. Nails may become opaque, white, thickened and brittle, and may be easily broken. Infected nails can provide a reservoir of dermatophytes that can cause repeated infections. Penlac Nail Lacquer is applied once a day with an applicator brush to all affected nails and immediately adjacent skin. Daily applications should be made over the previous coat and removed every seven days. Up to 48 weeks of daily applications, weekly trimming by the patient and monthly professional removal of the unattached, infected nail, is needed. Penlac Nail Lacquer was developed to provide topical therapy without systemic side effects. In controlled clinical trials it was found to be safe and effective in treating nail fungus, with some patients experiencing resolution of the infection. Ciclopirox has a long history of clinical use for other applications, and has been marketed worldwide for 25 years in cream, lotion and gel formulations and, in the U.S. since 1982. Ciclopirox is manufactured by Aventis Pharma Deutschland GmbH of Frankfurt, Germany, and will be marketed under the tradename Penlac Nail Lacquer (ciclopirox) Topical Solution 8%.
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