FDA OK's Valeant toenail fungus drug Jublia
This article was originally published in Scrip
After initially being rejected by the FDA, Valeant Pharmaceuticals won approval on 9 June to market Jublia (efinaconazole 10% topical solution) as the first topical triazole in the US for onychomycosis of the toenails.
Onychomycosis (tinea unguium) is a common and destructive nail infection which affects the toenails more often than the fingernails – accounting for one-third of integumentary fungal infections and one half of all nail disease.
Onychomycosis may indirectly decrease peripheral circulation, leading to worsening conditions, such as venous stasis and diabetic foot ulcers.
The condition has largely been undertreated because of the limitations of available treatments, Valeant said.
But Valeant's studies showed patients could be cured of onychomycosis with Jublia –17.8% vs 3.3% and 15.2% vs 5.5%, in two trials testing the drug against another vehicle.
Adverse events that were reported were generally mild and transient and were similar between subjects treated with Jublia and the other vehicle.
The most commonly reported adverse events in patients treated with Jublia were application site dermatitis and application site vesicles, Valeant reported.
The company, which initially received a complete response letter for Jublia last year, acquired the drug through its 2008 acquisition of Dow Pharmaceutical Sciences (scripintelligence.com, 29 May 2013).