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Drug Profiles

Efinaconazole (Jublia) for the treatment of onychomycosis

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Abstract

Efinaconazole 10% nail solution (Jublia®) is a new topical triazole antifungal designed for the topical treatment of distal and lateral subungual onychomycosis. It inhibits ergosterol biosynthesis enzyme sterol 14α-demethylase. Efinaconazole has lower minimum inhibitory concentrations than terbinafine, ciclopirox, itraconazole and amorolfine in Trichophyton rubrum, Trichophyton mentagrophytes and Candida albicans. The solution based formula has low surface tension and keratin binding properties that increase penetrance through the nail plate. Safety studies have shown that this formulation is not associated with atopic dermatitis or contact sensitivity. Duplicate Phase III clinical trials in adults with mild to moderate distal and lateral subungual onychomycosis indicate that efinaconazole 10% solution is an effective therapy with a pooled complete cure rate of 17% and a pooled mycological cure rate of 54%. Efinaconazole 10% nail solution is a safe and effective new topical therapy for onychomycosis, which will fill a pressing need for more effective topical therapy in this disease.

Financial & competing interests disclosure

AKG has served as a clinical trials investigator for Valeant Canada, Bristol Meyers Squibb, Eli Lilly, Merck, Novartis, Janssen and Allergan. AKG has served as a speaker for Valeant Canada and Bayer, as well as consulting for Anacor Pharmaceuticals. FCS is an employee of Mediprobe Research Inc. which conducts clinical trials under the supervision of AKG. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

  • There is a pressing need for effective topical drugs for the treatment of onychomycosis in individuals where oral therapy is not an option.

  • Efinaconazole is a novel triazole antifungal that was developed as a topical solution for the treatment of onychomycosis.

  • Efinaconazole 10% nail solution has superior complete and mycological cure rates to existing topical antifungal lacquers ciclopirox and amorolfine.

  • The most common treatment emergent adverse events associated with efinaconazole were erythema and application site dermatitis which resolved with treatment cessation.

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