#onychomycosis - new topical treatment approved by US FDA.

The US Food and Drug Administration (FDA) has just approved an antifungal called tavaborole 5% solution (Kerydin, Anacor Pharmaceuticals) for the topical treatment of toenail onychomycosis. Anacor specializes in drugs based on the element boron.

The drug is the second the FDA has approved within roughly a month for the topical treatment of toenail onychomycosis. On June , the agency cleared efinaconazole 10% solution (Jublia, Valeant Pharmaceuticals) for market take-off.

Tavaborole is indicated specifically for onychomycosis caused by Trichophyton rubrum or Trichophyton mentagrophytes. Label instructions call for once-a-day application to infected toenails for 48 weeks. Nail debridement is not necessary.

The FDA determined the efficacy and safety of tavaborole based on 2 multicenter, double-blind, randomized trials involving 1194 subjects. The primary endpoint was "complete cure," defined as a completely clear nail (0% clinical involvement), plus mycologic cure, consisting of a negative KOH test and a negative culture. Complete cure was found in 6.5% of patients using tavaborole in trial 1 and 9.1% of those in trial 2 compared with 0.5% and 1.5%, respectively, of patients applying the vehicle (control patients)..