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Valeant Pharmaceuticals announced positive results from two pivotal studies evaluating efinaconazole 10% topical solution in 1,655 subjects with onychomycosis. Efinaconazole is a triazole antifungal.
The two large, international, multicenter, randomized, double-blind, vehicle-controlled studies were conducted in subjects with onychomycosis affecting at least one great toenail. The toenail was required to have at least 20%–50% of clinical involvement. Study 1 had 870 subjects and Study 2 had 785. They were randomized in a 3:1 ratio to efinaconazole topical solution 10% or to vehicle. Treatment was applied once-daily for 48 weeks, with post-treatment follow-up occurring at Week 52. Debridement was not performed in the studies.
The primary endpoint was stringently defined as the complete cure rate at Week 52 (the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and by a negative fungal culture). In both studies, the primary endpoint was statistically significant (P<0.001) in favor of efinaconazole topical solution 10%. In Study 1, 17.8% of subjects treated with efinaconazole were completely cured vs. 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with efinaconazole were completely cured vs. 5.5% of subjects treated with vehicle.
Both studies also found that mycologic cure rates were also statistically significant (P<0.001) in favor of efinaconazole topical solution 10%. In Study 1, 55.2% of subjects treated with efinaconazole demonstrated mycologic cure vs. 16.8% of subjects treated with vehicle. In Study 2, 53.4% of subjects treated with efinaconazole demonstrated mycologic cure vs. 16.9% of subjects treated with vehicle. In addition, more patients treated with efinaconazole (Study 1: 26.4% and Study 2: 23.4%) achieved a complete or almost complete cure (<5% clinical involvement and mycologic cure) compared with vehicle (Study 1: 7% and Study 2: 7.5%; both P<0.001).
For more information call (800) 556-1937 or visit www.valeant.com.
