FDA OKs Another Topical Drug for Onychomycosis (Kerydin)

The US Food and Drug Administration (FDA) on July 7 approved an antifungal called tavaborole 5% solution (Kerydin, Anacor Pharmaceuticals) for the topical treatment of toenail onychomycosis.

Tavaborole is the first oxaborole-class topical antifungal for the toenail version of this infection, which also can develop in fingernails, according to a news release from the manufacturer. 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 6, 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, according to Anacor.

The FDA determined the efficacy and safety of tavaborole based on 2 multicenter, double-blind, randomized trials involving 1194 subjects. The trials compared the drug with topical “vehicles” that carry an active dermatological ingredient. Researchers assessed efficacy at 52 weeks after 48 weeks of treatment. 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.

Secondary endpoints were “complete or almost complete cure,” in which mycologic cure was accompanied by clinical involvement of 10% or less, and mycologic cure alone. Tavaborole posted significantly higher efficacy scores in these 2 categories.

Table. Tavaborole Efficacy Outcomes

Efficacy Variable Trial 1 Trial 2
Tavaborole Vehicle Tavaborole Vehicle
Complete cure 6.5% 0.5% 9.1% 1.5%
Complete or almost complete cure 15.3% 1.5% 17.9% 3.9%
Mycologic cure 31.1% 7.2% 35.9% 12.2%

Source: FDA

Common adverse events seen in the clinical trials included dermatitis, erythema, and exfoliation at the application site as well as ingrown toenail.

Date of article/Start date of trial: 9 February 2014



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