Two Phase III studies of efinaconazole (Valeant Pharma) show positive results in patients with Onychomycosis

Positive results have been published from two pivotal, Phase III multicenter, randomized, double-blind, vehicle-controlled studies of efinaconazole, from Valeant Pharma, that were conducted in 1,655 subjects with Onychomycosis. The study's primary endpoint was the complete cure rate at Week 52, meaning the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with efinaconazole were completely cured, as compared to only 3.3% of subjects treated with vehicle and in Study 2, 15.2% of subjects treated with efinaconazole were completely cured, as compared to only 5.5% of subjects treated with vehicle.

Using the secondary endpoint of complete or almost complete cure, defined as less than 5% clinical involvement and 100% mycologic cure, the success rates for efinaconazole increased to 26.4% and 23.4%, respectively. The adverse events that were reported were generally mild and transient. Results were published in the Journal of the American Academy of Dermatology. See: "Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double-blind studies." Boni E. Elewski et al. Journal of the American Academy of Dermatology, November 2012, doi:10.1016/j.jaad.2012.10.013