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Valeant Pharmaceuticals Announces Publication of Efinaconazole Phase III Results
Date:11/26/2012

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, which means that 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 of complete cure was statistically significant (P < .001) in favor of efinaconazole topical solution 10%.  In Study 1, 17.8% of subjects treated with efinaconazole were completely cured compared to only 3.3% of subjects treated with vehicle.   In Study 2, 15.2% of subjects treated with efinaconazole were completely cured compared to only 5.5% of subjects treated with vehicle. Although no head-to-head studies have been conducted, these results are comparable to that reported with oral treatment of onychomycosis. 

Both studies also found that mycologic cure rates were also statistically significant (P < .001) in favor of efinaconazole topical solution 10%.  In Study 1, 55.2% of subjects treated with efinaconazole demonstrated mycologic cure compared to only 16.8% of subjects treated with vehicle.   In Study 2, 53.4% of subjects treated with efinaconazole demonstrated mycologic cure compared to only 16.9% of subjects treated with vehicle.  Given that healthy toenails can take 78 weeks to grow completely, it is not surprising that mycologic cure rates are greater than complete cure rates.  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: 7.0% and Study 2: 7.5%; both P <.
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SOURCE Valeant Pharmaceuticals International, Inc.
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