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Onychomycosis

Onychomycosis is commonly known as toenail fungus.  It is a chronic fungal infection affecting the toenails and fingernails of approximately 35 million patients in the U.S. alone.  Only about 20% of these patients, or 7 million, seek professional care form a physician.  Clinical symptoms include yellow discoloration, thickening of the nail, subungual (under the nail) debris and loss of attachment of the nail plate to the nail bed.

The global market for onychomycosis treatments is estimated to be over $2.0B in 2010.

Though treatable, current therapeutic options are limited due to potential liver toxicity complications, long courses of drug treatment required to achieve an effect and low efficacy for commercially available topical medicines.

Nitric Bio believes that the treatment of onychomycosis can be greatly improved with the use of the company’s proprietary drug/device combination, which uses iontophoresis to deliver highly concentrated doses of a unique formulation of terbinafine, the most effective treatment for onychomycosis on the market today.  Through the use of iontophoresis in a simple 20 minute, in-office procedure, the drug is delivered directly to the site of the infection - on, around and under the toenail.  NB Therapeutics is conducting a one-year Phase 2 study, with patient enrollment completed  in December 2010.

More about Onychomycosis

While many of the effects of onychomycosis are cosmetic in nature, the disease can also cause pain, discomfort and disfigurement. Psychosocial and emotional effects stemming from onychomycosis are widespread and may have a significant impact on quality of life.  

Onychomycosis is usually asymptomatic; therefore, patients usually first present for cosmetic reasons without any physical complaints.  As the disease progresses, onychomycosis may interfere with standing, walking, and exercising.  Patients may report paresthesia (loss of sensation), pain, discomfort, and loss of dexterity. They also may report loss of self-esteem and lack of social interaction.

Onychomycosis is more likely to develop in patients with underlying conditions such as diabetes and peripheral arterial disease (PAD), as well as other conditions where blood circulation might be compromised.  In these patients, it is critical to aggressively treat the disease in order to avoid future complications such as bacteremias and other infections.

Current Onychomycosis Prescription Treatments

There are only a small number of products approved to treat onychomycosis, despite the tens of millions of patients who have sought effective treatments.  Current commercially available treatments are limited for a number of reasons:

• Generally poor efficacy (lack of penetration of topical drugs into toenail)
• Inconvenient and lengthy treatment regimens (240-300 days)
• Potential liver toxicity (long-term oral medications require liver function surveillance during treatment)

Of the 6-7 million patients who seek treatment in the U.S. annually, only about 50% of them receive a prescription.¹ Among the main reasons is that the most effective oral product, terbinafine (Lamisil), requires liver function tests, requires daily administration for 3 months and only has a cure rate between 38-59%, depending on the definition of cure used.² The most used topical onychomycosis product, ciclopirox, is only 8-10% effective, and must be applied to the infected nail every day for 270 days.

Importance of Treating Onychomycosis

Onychomycosis is a public health concern because of its high worldwide incidence and prevalence, and its potential for spread of fungal elements to others, as well as complications such as cellulitis, bacterial infection, pain, and extensive dermatophytic infections. The incidence of onychomycosis has been increasing, particularly in individuals over 60 years of age, patients with HIV infection and patients with diabetes mellitus. Onychomycosis may have a significant impact on physical, functional, psychosocial, and emotional aspects of life. Difficulty walking, wearing shoes, and embarrassment are common complaints. Quantification of such quality-of-life changes are significant to clinical practice in that many factors can affect overall patient health. In light of the potential clinical implications on physical and mental health, onychomycosis should be considered a medical condition that deserves rigorous clinical management.⁷

In addition to the very real medical issues, the appearance of toes and fingers with onychomycosis forces many patients to avoid social situations, skip work, etc. Drake et al completed a telephone survey of 258 patients with onychomycosis. The results showed that 193 patients (75%) reported embarrassment about their nails, and 124 patients (48%) reported pain associated with their condition. More than 58 onychomycosis-related sick days and 468 medical visits (1.8 per subject) were reported during a 6-month period. A total of 249 patients (97%) reported they would be willing to pay out-of-pocket for antifungal therapy with an 80% cure rate.⁸

 

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