The Journal of the American Academy of Dermatology has published the positive results from two pivotal, international, multicenter, randomized, double-blind, vehicle-controlled studies of efinaconazole 10% topical solution (Valeant Pharmaceuticals, www.valeant.com) for the treatment of onychomycosis. The Phase III studies were conducted in 1,655 subjects with onychomycosis. The only approved topical treatments are lacquers with limited efficacy and oral treatments, which--while more efficacious--are limited by drug interactions and numerous safety concerns including the potential for acute liver injury. Efinaconazole 10% topical solution is 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.
“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 at the 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 10 Americans suffer from onychomycosis. Furthermore, 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.”