Anacor announced that it has submitted a New Drug Application (NDA) to the FDA for tavaborole, its drug candidate for the topical treatment of onychomycosis, a fungal infection of the nail and nail bed.

Tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two Phase 3 pivotal studies 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.

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