FDA approves luliconazole for tinea pedis

This article was updated November 25, 2013 to correct an error in treatment duration. 

FDA has approved luliconazole (Luzu Cream, 1%, Valeant Pharmaceuticals) for the 2-week, once-daily treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients aged 18 years and older.

“The approval of Luzu Cream 1% for the treatment of athlete's foot provides another treatment option that will be  made available to patients who may not achieve relief from current treatments on the market,” said Formulary advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “The 1-week treatment period with Luzu Cream 1% compared to the 2-week treatment requirement for other agents can be viewed as a significant advantage of this newer agent which may foster its selection as the drug of choice."

Luzu has undergone 3 positive pivotal studies in the United States that were the basis for approval, according to a news release. The studies were conducted in 679 patients who had either tinea pedis or tinea cruris.

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

In study 1, 26% of patients treated with luliconazole demonstrated complete clearance, compared to 2% of patients treated with vehicle. In study 2, 14% of patients treated with luliconazole were completely cleared, compared to 3% of patients treated with vehicle.

For the study in tinea cruris, complete clearance was assessed at 3 weeks post-treatment. After one week of treatment, 21% of patients treated with luliconazole were completely cleared, compared to 4% of those treated with vehicle.

Application site reactions - the most common adverse events - were reported in less than 1% of patients for both luliconazole and vehicle.

All other approved treatments for these skin conditions require 2 weeks of treatment, according to the company. Luliconazole has been approved in Japan since 2005.