FDA Approves New Topical Antifungal Luliconazole 1%

Megan Brooks

November 15, 2013

The US Food and Drug Administration (FDA) has approved the azole antifungal luliconazole 1% cream (Luzu, Valeant Pharmaceuticals) to treat fungal infections, the company announced today.

Luliconazole 1% cream is indicated for the topical treatment of interdigital tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in adults aged 18 years and older.

It is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a 1-week, once-daily treatment regimen, the company notes. All other currently approved treatments require 2 weeks of treatment. For interdigital tinea pedis, the treatment period is 2 weeks, once daily.

The approval was based on 3 pivotal US trials conducted in 679 adults with either tinea pedis (2 trials) or tinea cruris (1 trial), the company notes in a news release.

For the 2 studies in tinea pedis with a treatment duration of 2 weeks, the primary endpoint was defined as complete clearance 4 weeks posttreatment, meaning the skin showed no clinical involvement and no evidence of fungus.

In study 1, 26% of participants treated with luliconazole were completely cleared compared with only 2% of those treated with vehicle. In study 2, 14% of participants treated with luliconazole were completely cleared compared with only 3% of those treated with vehicle.

In the tinea cruris trial, complete clearance was assessed 3 weeks posttreatment. After 1 week of treatment, 21% of patients treated with luliconazole were completely cleared compared with only 4% of those treated with vehicle.

The most common adverse events were mild application site reactions reported in less than 1% of subjects for both luliconazole and vehicle.

"This is the first safe and effective product indicated for daily use over a one-week period," J. Michael Pearson, Valeant's chairman and chief executive officer, said in a company release.

"This will be a welcome alternative to current options that require two weeks of treatment, and we believe Luzu will position us well to address this growing unmet need."


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