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FDA Okays Luzu (Luliconazole) Antifungal Cream
Topical azole agent treats three types of infection (November 15)
The FDA has approved the new drug application (NDA) for Luzu (luliconazole) cream, 1% (Valeant Pharmaceuticals). The product is indicated for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) caused by the organisms Trichophyton rubrum and Epidermophyton floccosum in patients 18 years of age and older. These are common skin diseases caused predominantly by dermatophyte fungi.
Luzu (luliconazole) cream, 1% is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a 1-week, once-daily treatment regimen. For interdigital tinea pedis, the cream is approved as a 2-week, once-daily treatment.
The FDA’s approval was based on results from three pivotal studies involving a total of 679 subjects with either tinea pedis or tinea cruris.
For the two pivotal studies in subjects with tinea pedis with a treatment duration of 2 weeks, the primary endpoint was complete clearance (i.e., the skin showed no clinical involvement and no evidence of fungus) at 4 weeks post-treatment. In the first study, 26% of subjects treated with Luzu were completely cleared, compared with 2% of subjects treated with vehicle. In the second study, 14% of subjects treated with Luzu were completely cleared, compared with 3% of subjects treated with vehicle.
For the pivotal study in subjects with tinea cruris, complete clearance was assessed at 3 weeks post-treatment. After 1 week of therapy, 21% of subjects treated with Luzu were completely cleared, compared with 4% of subjects treated with vehicle.
Source: Valeant Pharmaceuticals; November 15, 2013.