THERAPEUTIC MARKETS

Onychomycosis

According to the JAMA Archives of Family Medicine, approximately 20 percent of the U.S. population has onychomycosis, which is a very common fungal infection of the nails, causing thickening, roughness, discoloration and splitting. The infection involves the nail plate, the nail bed and in some cases, the skin surrounding the nail plate. Prevalence increases with age.

Onychomycosis of Toe Nails

The pharmaceutical market research firm, Datamonitor, estimate of worldwide sales of oral drugs for onychomycosis exceeds $1.4 billion. The two most commonly used drugs for this indication are Lamisil® and Sporanox®. Terbinafine, the active pharmaceutical ingredient in Lamisil, is a fungicidal agent that is particularly potent against the dermatophyte Trichophyton rubrum, which is the key causative agent in onychomycosis. Terbinafine became a generic drug in October 2006.

While currently available oral antifungal drugs effectively kill the organisms creating the condition, systemic treatment exposes the patient to unwanted side effects. The FDA has issued a black box health warning about potential heart and drug interaction problems associated with Sporonox, and Lamisil carries warnings regarding liver disease and drug interactions. These safety issues make the use of oral Sporonox and Lamisil problematic for treatment of fungal infections of the nails and skin, and underscore the need for a safer and more efficacious topical anti-fungal treatment regimen.

A novel treatment modality that delivers high local levels of drug and provides superior efficacy with minimal systemic exposure will rapidly redefine this market opportunity. Transport believes that its Electrokinetic Transungual System for onychomycosis is the first step-change in topical treatment of onychomycosis.