Anacor Pharmaceuticals announced positive preliminary results from the second of two Phase 3 studies of tavaborole (Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed.
The study enrolled 601 patients in the United States and Canada, randomized 2:1 to receive either tavaborole 5% solution or vehicle. Patients were instructed to apply tavaborole solution or vehicle to the target great toenail once daily for 48 weeks. The primary endpoint of the study was complete cure, a composite endpoint that required both a completely clear nail and mycological cure.
In both studies, tavaborole achieved statistically significant and clinically meaningful results for the primary endpoint. The Study 302 results at week 52 for the primary endpoint were reported as 9.1% in the active group and 1.5% in the vehicle group (P<0.001).
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