Efinaconazole 10% topical solution (Jublia, Valeant Pharmaceuticals North America LLC, received approval as the first topical triazole approved for the treatment of onychomycosis of the toenails. The licensor and business partner for efinaconazole, is Kaken Pharmaceutical.
Traditionally onychomycosis, the common and destructive nail infection, has been difficult to treat because of the limitations of available treatments. For example, over-the-counter or prescription topical treatments provide limited efficacy and are often administered in conjunction with frequent debridement, or the scraping, cutting or removal of the nail. Prescription oral treatments are limited by drug interactions and serious safety concerns.
“We acquired Jublia through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia from pre-IND stage through Clinical Phases 1, 2 and 3,” explains J. Michael Pearson, chairman and chief executive officer of Valeant. “We are working quickly to get this important product launched in the U.S. and Canada in the third quarter of 2014.”
He notes that the company anticipates favorable managed care coverage in the U.S., similar to other branded antifungal agents.
