NEXMED STARTS PATIENT DOSING IN NAIL FUNGUS STUDY

NexMed announced that its collaborator, Novartis, has commenced dosing of patients in the Phase III clinical trials for NM100060, a topical treatment for onychomycosis (nail fungus). NexMed signed an exclusive, worldwide licensing agreement with Novartis in 2005, under which Novartis has assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.

The Phase III program for NM100060 consists of two pivotal, randomized, double-blind, placebo-controlled studies. The parallel-group studies are designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate onychomycosis. Approximately 1,000 patients will participate in the two studies, which will take place in the U.S., Europe, Canada and Iceland.

NM100060 is a topical application of Lamisil (terbinafine), formulated with terbinafine and the NexACT permeation enhancer, which facilitates the delivery of the drug into the nail bed where the fungus resides.

NexACT is designed to overcome the skin's natural barriers, enabling high concentrations of active drugs to rapidly penetrate the skin. The technology's cellular mechanism of action has shown to increase the permeability of the cell membrane in a time- and concentration-dependent manner. For a drug with a narrow therapeutic index, NexACT may provide a controlled rate of administration, which is a significant advantage for maintaining efficacy while reducing toxicity, according to NexMed.