Naftin (naftifine HCl) Gel 2%, Merz North America), received FDA approval on July 1, 2013, for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum in patients 18 years of age and older. Naftin Gel 2%, which will be available in the fall of 2013, is an improvement on the previously approved formulation Naftin (naftifine HCl) Gel 1%, according to the company. Studies with the topical medication, which is applied once a day for 2 weeks, demonstrated continuous improvement in post-treatment efficacy rates for up to 4 weeks after the regimen had ended.
Naftin Gel 2% was approved after the results of 2 clinical trials involving 47 investigational sites and 1715 patients were analyzed. In these studies, the patients treated with Naftin 2% achieved significantly higher cure rates compared with placebo. The medication also achieved high safety results, and the most common adverse events were application skin reactions.
