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Valeant Pharmaceuticals Announces Publication Of Efinaconazole Phase III Results

Stocks in this article: VRX

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 results from the two Phase III studies of efinaconazole with the publication by a leading dermatology journal," stated J. Michael Pearson, chairman and chief executive officer.  "While oral treatment of onychomycosis has been the standard of care, drug interactions and risk of acute liver injury may limit their use especially in older adults where disease is most prevalent, those on multiple drug regimens, or for patients or doctors who prefer topical therapies. As no new onychomycosis treatments have been introduced for over 10 years, we believe in the authors' conclusion that this may be the first topical treatment option for DLSO that can be considered a viable alternative to oral treatments."

"This is a very exciting time for patients with the pending launch of the first new topical anti-fungal treatment approved in more than a decade," said Boni Elewski, MD Professor of Dermatology, University of Alabama.  "Onychomycosis is a common infection that, left untreated, can later appear not only on other toes and fingers, but also on friends and family, too. It is estimated that one in ten Americans suffer from onychomycosis, which causes the nail to thicken and can be quite painful, making this condition more than just a cosmetic problem.  Furthermore, as some research indicates that up to half of patients over the age of 70 suffer from this progressive disease. An effective topical therapy like efinaconazole is a logical treatment option to avoid drug interactions and systemic side effects, as these patients undoubtedly take other oral medications."

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Trial Design

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.

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