Anacor files tavaborole at FDA for Onychomycosis

Anacor Pharmaceuticals announced that on July 26, 2013 it submitted its New Drug Application (NDA) to the FDA for tavaborole, its drug candidate for the topical treatment of Onychomycosis. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.

Anacor announced earlier this year that tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two Phase III pivotal studies of tavaborole to treat Onychomycosis topically without concomitant debridement. The only currently FDA-approved topical treatment for onychomycosis is approved with concomitant nail debridement, and currently approved oral therapies have been associated with rare but serious safety issues.