FDA Approves Topical Treatment for Onychomycosis
The FDA has approved tavaborole topical solution 5% (Kerydin, Anacor Pharmaceuticals) for the treatment of onychomycosis of the toenails.
Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
The alcohol-based solution can be applied with a dropper to the infected toenail once daily for 48 weeks. Debridgement of the nail is not required.
The solution was tested in 2 multi-center, double-blind trials involving 1194 participants; 6.5% to 9.1% of subjects reached the primary endpoint of a complete cure at 52 weeks vs 0.5% to 1.5% in the control groups.
Side effects, which occurred in at least 1% of treated subjects, included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis.
Anacor. FDA approves Anacor Pharmaceuticals Kerydin (tavaborole) topical solution, 5% for the treatment of onychomycosis of the toenails [press release]. July 8, 2014. http://investor.anacor.com/releasedetail.cfm?ReleaseID=858211. Accessed July 9, 2014.