August 2013

Toenail topical shows efficacy in trials

A topical antifungal manufactured by Palo Alto, CA-based Ancor Pharmaceuticals clears nails and fungal infection in people with onychomycosis, according to data presented in July at the 2013 American Podiatric Medical Association Annual Scientific Meeting held in Las Vegas.

Max Weisfeld DPM, a podiatrist in private practice in Baltimore, MD, reported on results of two phase 3 trials of tavaborole that showed the boron-based agent cleared nails and cured fungal infection in about 27% and 35% of study participants, respectively. The two trials involved 600 people randomized to apply either tavaborole or a placebo once daily for 48 weeks.

Weisfeld noted participants achieved statistically significant and clinically meaningful results without concomitant nail debridement, which is a drawback of ciclopirox, the only topical currently approved by the Food and Drug Administration (FDA) for onychomycosis. Current oral therapies, such as terbinafine, are associated with rare cases of liver failure and death.

Anacor is seeking approval for tavaborole from the FDA and will soon file a New Drug Application for the agent.

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