Biology:Efinaconazole
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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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| Formula | C18H22F2N4O |
| Molar mass | 348.398 g·mol−1 |
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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]
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
- ↑ "Archived copy". https://pdf.hres.ca/dpd_pm/00054721.PDF.
- ↑ 2.0 2.1 2.2 2.3 2.4 "Jublia- efinaconazole solution". 30 September 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=922d4d25-c530-11e1-9b21-0800200c9a66.
- ↑ "Efinaconazole: first global approval". Drugs 73 (17): 1977–1983. Nov 2013. doi:10.1007/s40265-013-0152-x. PMID 24249649.
- ↑ "Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study". J Drugs Dermatol 12 (2): 186–192. Feb 2013. PMID 23377392.
- ↑ "Mechanism of action of efinaconazole, a novel triazole antifungal agent". Antimicrob Agents Chemother 57 (5): 2405–2509. May 2013. doi:10.1128/aac.02063-12. PMID 23459486.
- ↑ "Efinaconazole: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211851.
- ↑ "Efinaconazole: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211827.
- ↑ "First Generic Drug Approvals". https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals.
- ↑ "Competitive Generic Therapy Approvals". 3 March 2023. https://www.fda.gov/drugs/generic-drugs/competitive-generic-therapy-approvals.
- ↑ "Drug Approval Package: Jublia topical solution (efinaconazole) NDA #203567". 24 December 1999. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm.
- ↑ 11.0 11.1 "Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis". Valeant Pharmaceuticals (Press release). 9 June 2014. Archived from the original on 8 November 2015. Retrieved 1 November 2015.
- ↑ "FDA Approves Ortho Dermatologics' Labeling For Jublia (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old". Bausch Health (Press release). Archived from the original on 10 June 2022. Retrieved 10 June 2022.
- ↑ "Cost-effectiveness of Confirmatory Testing Before Treatment of Onychomycosis". JAMA Dermatology 152 (3): 1–6. 2015. doi:10.1001/jamadermatol.2015.4190. PMID 26716567.
- ↑ "Table 5, CDR Cost Comparison Table for Onychomycosis". 8 June 2019. https://www.ncbi.nlm.nih.gov/books/NBK543377/table/pe.app1.tab1/.
External links
- "Efinaconazole". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/efinaconazole.
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