Efinaconazole Explained

Tradename:Jublia, Clenafin
Dailymedid:Efinaconazole
Licence Us:Efinaconazole
Routes Of Administration:Topical
Atc Prefix:D01
Atc Suffix:AC19
Legal Ca:Rx-only
Legal Ca Comment:[1]
Legal Us:Rx-only
Cas Number:164650-44-6
Pubchem:489181
Drugbank:DB09040
Chemspiderid:428538
Unii:J82SB7FXWB
Kegg:D10021
Chebi:82718
Chembl:2103877
Iupac Name:(2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
C:18
H:22
F:2
N:4
O:1
Smiles:C[C@H]([C@](CN1C=NC=N1)(C2=C(C=C(C=C2)F)F)O)N3CCC(=C)CC3
Stdinchi:1S/C18H22F2N4O/c1-13-5-7-23(8-6-13)14(2)18(25,10-24-12-21-11-22-24)16-4-3-15(19)9-17(16)20/h3-4,9,11-12,14,25H,1,5-8,10H2,2H3/t14-,18-/m1/s1
Stdinchikey:NFEZZTICAUWDHU-RDTXWAMCSA-N

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).[2] [3] Efinaconazole acts as a 14α-demethylase inhibitor.[4] [5]

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.

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. 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)).

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.

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 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]

External links

Notes and References

  1. Web site: Archived copy . 10 June 2022 . 10 June 2022 . https://web.archive.org/web/20220610041646/https://pdf.hres.ca/dpd_pm/00054721.PDF . live .
  2. Drugs . Nov 2013 . 73 . 17 . 1977–1983 . 10.1007/s40265-013-0152-x . Efinaconazole: first global approval . Patel T, Dhillon S . 24249649. 40015633 .
  3. 23377392 . J Drugs Dermatol . Feb 2013 . 12 . 2 . 186–192 . Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study . Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R .
  4. Tatsumi Y, Nagashima M, Shibanushi T . Mechanism of action of efinaconazole, a novel triazole antifungal agent . Antimicrob Agents Chemother . May 2013 . 57 . 5 . 2405–2509 . 10.1128/aac.02063-12. etal. 3632939 . 23459486.
  5. Web site: Jublia- efinaconazole solution . DailyMed . 30 September 2016 . 27 April 2020 . 30 November 2020 . https://web.archive.org/web/20201130215024/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=922d4d25-c530-11e1-9b21-0800200c9a66 . live .
  6. Web site: Efinaconazole: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 14 February 2021 . 21 March 2021 . https://web.archive.org/web/20210321113423/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211851 . live .
  7. Web site: Efinaconazole: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 14 February 2021 . 21 March 2021 . https://web.archive.org/web/20210321031109/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211827 . live .
  8. Web site: First Generic Drug Approvals . U.S. Food and Drug Administration (FDA) . 13 February 2021 . 26 January 2021 . https://web.archive.org/web/20210126083800/http://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/first-generic-drug-approvals . live .
  9. Web site: Competitive Generic Therapy Approvals . U.S. Food and Drug Administration (FDA) . 3 March 2023 . 6 March 2023.
  10. Web site: Drug Approval Package: Jublia topical solution (efinaconazole) NDA #203567 . U.S. Food and Drug Administration (FDA) . 24 December 1999 . 27 April 2020 . 29 May 2020 . https://web.archive.org/web/20200529221245/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm . live .
  11. Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis . Valeant Pharmaceuticals . 9 June 2014 . 1 November 2015 . https://web.archive.org/web/20151108032544/http://ir.valeant.com/investor-relations/news-releases/news-release-details/2014/Valeant-Pharmaceuticals-Announces-FDA-Approval-Of-Jublia-for-the-Treatment-of-Onychomycosis/default.aspx . 8 November 2015 . dead .
  12. FDA Approves Ortho Dermatologics' Labeling For Jublia (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old. Bausch Health. 10 June 2022. 10 June 2022. https://web.archive.org/web/20220610041651/https://ir.bauschhealth.com/news-releases/2020/04-29-2020-120230152. live.
  13. Mikailov A, Cohen J, Joyce C, Mostaghimi A . Cost-effectiveness of Confirmatory Testing Before Treatment of Onychomycosis . JAMA Dermatology . 2015. 152 . 3 . 26716567 . 10.1001/jamadermatol.2015.4190 . 1–6. free . doi .
  14. Web site: Table 5, CDR Cost Comparison Table for Onychomycosis. 8 June 2019. www.ncbi.nlm.nih.gov. 10 June 2022. 10 June 2022. https://web.archive.org/web/20220610041652/https://www.ncbi.nlm.nih.gov/books/NBK543377/table/pe.app1.tab1/. live.

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