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Jublia (Efinaconazole) Receives Regulatory Approval for Treatment of Onychomycosis

Topical antifungal solution provides complete cure in some patients

The FDA has approved the new drug application for Jublia (efinaconazole 10% topical solution, Valeant Pharmaceuticals International/Kaken Pharmaceutical), the first topical triazole antifungal agent indicated for the treatment of distal lateral subungual onychomycosis (onychomycosis of the toenails).

The U.S. launch is expected in the third quarter of 2014.

The topical solution is applied daily to the affected nail with a bottle that has a built-in brush applicator. There is no risk of systemic side effects, such as drug–drug interactions or acute liver injury.

Positive results from two pivotal clinical trials provided the basis for the FDA’s approval. The studies involved 1,655 subjects with onychomycosis. The data were published last year in the Journal of the American Academy of Dermatology.

The primary endpoint for both trials was a complete cure at week 52, which required that the target nail show no clinical involvement and no evidence of fungus by both potassium hydroxide (KOH) testing and a negative fungal culture. In one study, 17.8% of subjects treated with efinaconazole topical solution were completely cured, compared with 3.3% of subjects treated with vehicle. In the other study, 15.2% of subjects treated with efinaconazole were completely cured, compared with 5.5% of subjects treated with vehicle.

Adverse events were generally mild and transient, and were similar between subjects treated with efinaconazole topical solution or vehicle. The most commonly reported adverse events in patients treated with efinaconazole were application-site dermatitis and application-site vesicles.

Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi. It typically occurs under the toenail, although fingernails may also be affected. Approximately 35 million Americans have onychomycosis. Most are men between 50 and 70 years of age.

The fungi that cause onychomycosis live in warm, moist environments, including swimming pools and showers, and may invade the skin through tiny cuts or small separations between the nail and the nail bed.

The condition typically begins as a small white or yellow spot beneath the nail. As it progresses, the infection causes nail discoloration, thickening, and/or distortion; pain; detachment of the nail from the nail bed; and irregular surface changes. Once onychomycosis begins, it can persist indefinitely if not treated and may cause permanent nail damage. Currently, 85% of individuals with onychomycosis are untreated.

Source: Valeant Pharmaceuticals; June 9, 2014.

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