First Triazole Topical Solution Approved for Toenail Onychomycosis

Valeant announced that the FDA has approved Jublia (efinaconazole 10%) topical solution for the treatment of onychomycosis of the toenails (distal lateral subungual onychomycosis [DLSO]). Jublia is the first topical triazole approved for this indication.

The approval was based on data from 2 positive studies that studied 1,655 patients with onychomycosis. The primary endpoint was complete cure at Week 52, defined as the target nail showing 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 Jublia experienced complete cure vs. only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with Jublia experienced complete cure vs. only 5.5% of subjects treated with vehicle.

RELATED: Results of Phase 3 Studies Evaluating Efinaconazole for Onychomycosis Announced

Jublia topical solution is available in a novel bottle with a built-in flow-through brush applicator with fast drying properties. The product is expected to launch in the 3rd quarter of 2014.

For more information call (800) 556-1937 or visit Valeant.com.

Loading links....