Efinaconazole

Efinaconazole
Clinical data
Trade namesJublia, Clenafin
AHFS/Drugs.comMonograph
MedlinePlusa614050
License data
Routes of
administration		Topical (solution)
ATC code
Legal status
Legal status
Identifiers
IUPAC name
  • (2R,3R)-2-(2,4-Difluorophenyl)-3-(4-methylene-1-piperidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.245.862
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Chemical and physical data
FormulaC18H22F2N4O
Molar mass348.398 g·mol−1
3D model (JSmol)
SMILES
  • C[C@H]([C@](CN1C=NC=N1)(C2=C(C=C(C=C2)F)F)O)N3CCC(=C)CC3
InChI
  • InChI=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
  • Key:NFEZZTICAUWDHU-RDTXWAMCSA-N

Efinaconazole, sold under the brand names Jublia and Clenafin, is a triazole antifungal. 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][1]

It was approved as a generic medication in the United States in 2020.[5][6][7]

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.[1]

In two clinical trials 17.8% and 15.2% of patients using efinaconazole were cured, compared to 3.3% and 5.5% of patients using a placebo.[1]

Efinaconazole is not especially effective, but it is currently the best topical treatment available, with cure rates two or three times better than the next best topical treatment, ciclopirox. It is considered a reasonable option for patients with mild cases, or patients who can not take oral treatment.[8]

History

In 2014, the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA).[9][10] According to Valeant Pharmaceuticals International Inc CEO J. Michael Pearson they acquired Jublia through their purchase of Dow Pharmaceutical Sciences in 2008.[10]

Society and culture

Economics

In 2015, the cost of treatment with efinaconazole in the United States was said to be $2307 per nail.[11] The cost of treatment can be reduced to $65 per 1-month dose using Drug coupons, bringing the treatment cost to $715 per nail.[12]

References

  1. 1 2 3 4 "Jublia- efinaconazole solution". DailyMed. 30 September 2016. Retrieved 27 April 2020.
  2. ↑ Patel T, Dhillon S (November 2013). "Efinaconazole: first global approval". Drugs. 73 (17): 1977–1983. doi:10.1007/s40265-013-0152-x. PMID 24249649. S2CID 40015633.
  3. ↑ Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R (February 2013). "Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study". J Drugs Dermatol. 12 (2): 186–192. PMID 23377392.
  4. ↑ Tatsumi Y, Nagashima M, Shibanushi T, et al. (May 2013). "Mechanism of action of efinaconazole, a novel triazole antifungal agent". Antimicrob Agents Chemother. 57 (5): 2405–2509. doi:10.1128/aac.02063-12. PMC 3632939. PMID 23459486.
  5. ↑ "Efinaconazole: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 14 February 2021.
  6. ↑ "Efinaconazole: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 14 February 2021.
  7. ↑ "First Generic Drug Approvals". U.S. Food and Drug Administration (FDA). Retrieved 13 February 2021.
  8. ↑ "A Closer Look At A New Topical Option For Onychomycosis". Retrieved 21 May 2015.
  9. ↑ "Drug Approval Package: Jublia topical solution (efinaconazole) NDA #203567". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 27 April 2020.
  10. 1 2 "Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis". Valeant Pharmaceuticals. Laval, Quebec. 9 June 2014. Archived from the original on 8 November 2015. Retrieved 1 November 2015.
  11. ↑ Mikailov A, Cohen J, Joyce C, Mostaghimi A (2015). "Cost-effectiveness of Confirmatory Testing Before Treatment of Onychomycosis". JAMA Dermatology. 152 (3): 1–6. doi:10.1001/jamadermatol.2015.4190. PMID 26716567.
  12. ↑ "Ortho Dermatologics Access Program". www.orthorxaccess.com. Retrieved 10 August 2021.
  • "Efinaconazole". Drug Information Portal. U.S. National Library of Medicine.
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