Anacor Pharmaceuticals, Inc. ANAC, announced on Jul 08, 2014 that the FDA has approved the New Drug Application for Tavaborole, which is marketed as KERYDIN™ topical solution, 5%. Tavaborole was designed to be convenient for patients to use and it’s the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.
Onychomycosis is a progressive, recurring fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today.
Tavaborole is a broad-spectrum oxaborole antifungal agent with low molecular weight, permitting optimal nail plate penetration. Tavaborole is a clear, colorless, alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks. Debridement of the nail is not required during the treatment period. Due to its topical application, KERYDIN has low systemic absorption and has not demonstrated systemic side effects.
Studies have demonstrated the superior nail-penetrating properties of tavaborole compared to existing topical antifungal medications approved for the treatment of onychomycosis.
Onychomycosis is one of the most common diseases diagnosed causing approximately one-half of all nail disorders, and it’s prevalence has been steadily increasing. It is difficult to treat, partly due to the subungual location and the inability of both oral and topical antifungals to reach the site of infection. Historically, a large number of patients with onychomycosis would choose not to treat their infection. With the approval of Tavaborole, physicians can now offer patients a safe, effective and easy-to-use topical treatment for their onychomycosis of the toenail.
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