FDA approves new topical onchomycosis drug

June 9, 2014

The Food and Drug Administration approved a new drug application for Jublia (efinaconazole 10 percent, Valeant), a topical treatment for onychomycosis of the toenails.

The Food and Drug Administration approved a new drug application for Jublia (efinaconazole 10 percent, Valeant), a topical treatment for onychomycosis of the toenails.

Jublia, developed to treat distal lateral subungual onychomycosis, is the first topical triazole antifungal agent approved to treat the condition, according to a news release. The topical solution is applied daily to the affected area using a built-in “flow-through” brush applicator.

Valeant acquired Jublia when it purchased Dow Pharmaceutical Sciences in 2008. The drug was in its pre-investigational new drug stage at the time, and then was pushed through phase 1, 2 and 3 trials to determine its efficacy.

In clinical trials of 1,655 patients with onychomycosis, 17.8 percent of patients using Jublia were completely cleared in one study, compared to 3.3 percent of patients treated with vehicle. In a second study, 15.2 percent of patients treated with Jublia demonstrated complete cure, compared to 5.5 percent of those treated with vehicle.

Side effects were generally mild and transient. The most commonly reported adverse event among patients using Jublia were application site dermatitis and application site vesicles.

Valeant projects to have Jublia available in the United States and Canada by the third quarter of 2014, J. Michael Pearson, Valeant CEO and chairman said in a news release.

“We have also filed a new treatment for acne, Onexton, which has a PDUFA date of Nov. 30,” he said. “All these compounds came through our Dow acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory.”

Read more about onychomycosis:

Cuticle removal can induce onychomycosis

Onychomycosis armamentarium set to expand with new options

Prolonged treatment may be needed with pediatric onychomycosis