Anacor Submits NDA, Presents Data for Tavaborole

August 30, 2013

Anacor Pharmaceuticals has submitted an NDA to the FDA for for Tavaborole, its drug candidate for the topical treatment of onychomycosis. The company recently reported data presented at this summer's 2013 APMA Annual Scientific Meeting. Findings show that active treatment statistically significantly out-performed vehicle in all primary and secondary endpoints, including complete clearance and mycological cure. The data, from two separate Phase 3 studies of tavaborole on patients with distal subungual onychomycosis affecting 20 to 60 percent of the target great toenail, involved approximately 600 patients aged 18 years and older with no upper age limit (the oldest subject was 88 years old). Subjects were randomized two-to-one to receive either tavaborole or the vehicle control applied to the toenail once daily for 48 weeks.

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