Disease scope, pathology and implications.
Onychomycosis is a disease of the toenail, fingernail and nail bed. While not life-threatening, the disease can significantly impact quality of life. It’s estimated that onychomycosis affects 10% to 12% of the world’s adult population and as many as 35 million people in the United States alone1.
Against a backdrop of suboptimal treatments and inconvenient regimens, millions of people continue to suffer the physical and emotional effects of onychomycosis.
Onychomycosis, or fungal infections of the nail and nail bed, can cause pain, discomfort and psychosocial suffering that significantly impact quality of life.
Characterized by the chronic infection of the nail or nail bed by various fungi and yeasts, onychomycosis can present with discoloration, thickening, brittleness and eventual detachment of the nail. The condition can be painful, cause a loss of dexterity and interfere with the patient’s ability to stand, walk or exercise. Moreover, fungal nail infections can have psychosocial and emotional effects, with implications on overall patient health.
The incidence of onychomycosis has been increasing, particularly amongst the elderly and patients with immunodeficiency diseases, diabetes and circulatory disorders2.
Current prescription treatment challenges.
Onychomycosis is extremely difficult to treat because the causative fungal infection resides in the nail bed underneath the tough, keratinous nail plate.
The only FDA-approved topical treatment yields cure rates of 5.5% to 8.5% after a year of treatment3. Systemic orals yield cure rates ranging from 17% to 38%4, require hepatic monitoring and are frequently associated with various adverse reactions, drug-drug interactions and toxicities due to the doses required to concentrate therapy at the actual site of infection.
Tens of millions of onychomycosis patients go untreated. It is postulated that this is due to the associated ineffectiveness and adverse side effects of current treatments.
Clearly, there is urgent need for a highly effective and safe, patient-friendly, accessible therapeutic option.
1 Scher, RK et al. Onychomycosis: diagnosis and definition of cure. JAAD. 2007;56:939-44.
2 De Berker, D. Fungal nail disease. New England Journal of Medicine. 2009;360:2108-16.
3 Penlac® package insert.
4 Lamisil® and Sporonox® package inserts.
