FDA Approves New Nail Fungus Treatment
June 12, 2014 -- A new nail fungus treatment, the first that can be applied directly to the nail, has been approved by the U.S. Food and Drug Administration.
The topical treatment Jublia is for people with onychomycosis. It's a nail infection caused by a fungus that typically occurs under toenails, but it can also occur under fingernails, the Associated Press reported Wednesday.
About 35 million Americans have the condition, which most often affects men aged 50 to 70.
Jublia (efinaconazole) is made by a Canadian company called Valeant Pharmaceuticals International Inc., the AP reported.
Jublia comes in liquid form and is applied directly to the nail. According to Valeant, FDA approval was based on two studies involving more than 1,600 people with the nail infection. The findings were published last year in the Journal of the American Academy of Dermatology. Cure rates were about 18 percent for the patients involved in one study, and about 15 percent for those involved in the other.
In a statement, Valeant said it plans to begin marketing Jublia late in 2014.