MONTREAL, Nov. 26, 2012 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced today that the Journal of the American Academy of Dermatology has published the positive results from our two pivotal, international, multicenter, randomized, double-blind, vehicle-controlled studies that were conducted in 1,655 subjects with onychomycosis. Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi, resulting in nail destruction and deformity. The only approved topical treatments are lacquers with very limited efficacy. Oral treatments, while more efficacious, are limited by drug interactions and numerous safety concerns including the potential for acute liver injury. Valeant investigated the safety and efficacy of efinaconazole 10% topical solution (efinaconazole), the first triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).
The study's primary endpoint was stringently defined as the complete cure rate at Week 52, which means that 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 < 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 and were similar between subjects treated with efinaconazole solution 10% and vehicle.
"We are pleased to share the positive resu
|SOURCE Valeant Pharmaceuticals International, Inc.|
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