Anacor Pharmaceuticals submits tavaborole NDA to FDA for treatment of onychomycosis

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today that on July 26, 2013 it submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (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 was founded eleven years ago based on the promise of boron chemistry. Tavaborole is the first drug in our pipeline to reach this important milestone, and I'd like to acknowledge and thank the entire Anacor team for their hard work, dedication and persistence.”

"The submission of the NDA is a significant milestone for Anacor," said David Perry, Anacor's Chief Executive Officer. "Anacor was founded eleven years ago based on the promise of boron chemistry. Tavaborole is the first drug in our pipeline to reach this important milestone, and I'd like to acknowledge and thank the entire Anacor team for their hard work, dedication and persistence."

Anacor announced earlier this year that tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two Phase 3 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.