FDAnews
www.fdanews.com/articles/70708-nexmed-completes-enrollment-for-study-of-topical-antifungal-treatment

NexMed Completes Enrollment for Study of Topical Antifungal Treatment

April 5, 2005

NexMed has completed enrollment for its Phase I study of NM100060, NexMed's proprietary nail lacquer treatment for onychomycosis (nail fungal infection).

The U.S. Phase I study enrolled a total of 60 patients. The study is double-blind, randomized, parallel designed to assess the safety and pharmacokinetics of NM100060. In the study, the nail lacquer is applied twice a day for 28 days by patients with onychomycosis.

NexMed's lacquer product incorporates NexACT, and is applied directly to the nail and delivers a low dose of terbinafine HCl into the nail bed. Terbinafine is the active ingredient in the leading oral product marketed for treating onychomycosis.