Good Trial Results With Penederm Antifungal

Kaken Pharmaceutical's butenafine hydrochloride (benzylamine KP-363), a proprietary prescription antifungal licensed to Penederm Inc and currently awaiting US Food and Drug Administration approval, is highly effective in reducing the clinical signs and symptoms of interdigital tinea pedis (athlete's foot), with a long duration of action and virtually no side effects. This was reported by clinicians at the American Academy of Dermatology conference.

According to lead investigator Eduardo Tschen of Academic Dermatology Associates, Albuquerque, New Mexico, "butenafine achieved highly significant statistical results" in two randomized double-blind trials, eliminating fungi from tinea lesions in more than 80% of subjects. Butenafine-treated patients exhibited mycological cure rates of 90% and 88% after four weeks of once-daily treatment. In addition, said Dr Tschen, a high incidence of mycological cure was observed among treated patients four weeks after the completion of treatment, which is evidence of the drug's efficacy and long duration of action.

A total of 269 patients with interdigital tinea pedis were evaluated in two multi-center, vehicle-controlled, parallel, randomized, double-blind Phase III studies. Subjects were randomly assigned to treatment with 1% butenafine HCl cream or an identical vehicle without the active agent.