Efinaconazole

(Jublia®)

Jublia®

Drug updated on 11/1/2024

Dosage FormSolution (topical: 10%)
Drug ClassAzole antifungals
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Efinaconazole 10% solution demonstrated higher effectiveness than vehicle in achieving complete cure (RR (relative risk) 3.54, 95% CI (confidence interval) 2.24 to 5.60; high-quality evidence), clinical cure (RR 3.07, 95% CI 2.08 to 4.53; high-quality evidence), and mycological cure (RR 2.31, 95% CI 1.08 to 4.94; moderate-quality evidence).
  • Tavaborole 5% solution likely increases complete cure rates (RR 7.40, 95% CI 2.71 to 20.24; moderate-quality evidence) and mycological cure rates (RR 3.40, 95% CI 2.34 to 4.93; high-quality evidence) compared to vehicle.
  • Ciclopirox 8% lacquer may be more effective than vehicle for complete cure (RR 9.29, 95% CI 1.72 to 50.14; low-quality evidence) and likely improves mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence).
  • Efinaconazole 10% solution showed a slightly higher risk of adverse events, including dermatitis and vesicles (RR 1.10, 95% CI 1.01 to 1.20; high-quality evidence), while tavaborole 5% solution likely increased application site reactions (RR 3.82, 95% CI 1.65 to 8.85; moderate-quality evidence).
  • Ciclopirox 8% lacquer and luliconazole 5% solution showed varying adverse event profiles, with ciclopirox potentially leading to application reactions and rashes (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence) and luliconazole showing minimal difference in adverse events compared to vehicle (RR 1.02, 95% CI 0.90 to 1.16; low-quality evidence).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Jublia (efinaconazole) Prescribing Information.2022Bausch Health US LLC, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Therapeutic recommendations for the treatment of toenail onychomycosis in the US.2021Journal of Drugs in Dermatology