Efinaconazole, sold under the brand name Jublia among others, is a triazole antifungal medication. It is approved for use in the United States, Canada, and Japan as a 10% topical solution for the treatment of onychomycosis (fungal infection of the nail).[3][4] Efinaconazole acts as a 14α-demethylase inhibitor.[5][2]
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| Trade names | Jublia, Clenafin |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a614050 |
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| Routes of administration | Topical |
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| ECHA InfoCard | 100.245.862 |
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| Formula | C18H22F2N4O |
| Molar mass | 348.398 g·mol−1 |
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It is available as a generic medication.[6][7][8][9]
Medical uses
Efinaconazole is an azole antifungal indicated in the US for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.[2]
Efficacy
In two clinical trials 17.8% (trial 1) and 15.2% (trial 2) of participants using efinaconazole were completely cured (0% clinical involvement of the target toenail, plus negative KOH test and negative culture), compared with 3.3% (trial 1) and 5.5% (trial 2) of participants using a placebo.[2] The "complete cure or almost complete cure" rate (≤5% affected target toenail area involved, and negative KOH and culture) for efinaconazole was 26.4% (trial 1) and 23.4% (trial 2) (compared with 7.0% (trial 1) and 7.5% (trial 2)).[2]
History
In 2014, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA).[10][11] According to Valeant Pharmaceuticals International Inc CEO J. Michael Pearson they acquired Jublia through their purchase of Dow Pharmaceutical Sciences in 2008.[11]
In 2020, the FDA approved a supplemental New Drug Application for efinaconazole topical solution, 10%, which extended the age range included in the product's label to children six years of age and older; it was first approved in 2014, in people aged 18 years of age and older.[12]
Society and culture
Economics
In 2015, the cost of treatment with efinaconazole in the United States was said to be US$2,307 per nail.[13]
In 2019, a study by the Canadian Agency for Drugs and Technologies in Health found the cost for a 48-week course to be $178 for a big toe, and $89 for an other toe.[14]
References
External links
- "Efinaconazole". Drug Information Portal. U.S. National Library of Medicine.
