Efinaconazole

(Jublia®)

Jublia®

Drug updated on 9/4/2024

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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  • Jublia (efinaconazole) is indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Efinaconazole's Effectiveness: Demonstrated a significant increase in complete cure (RR 3.54, 95% CI 2.24 to 5.60), clinical cure (RR 3.07, 95% CI 2.08 to 4.53), and mycological cure (RR 2.31, 95% CI 1.08 to 4.94) compared to vehicle in participants with onychomycosis.
  • Comparison of Topical Treatments: Tavaborole 5% solution was likely more effective in achieving complete cure (RR 7.40, 95% CI 2.71 to 20.24) and mycological cure (RR 3.40, 95% CI 2.34 to 4.93) compared to other topicals. Ciclopirox 8% lacquer showed potential for complete cure (RR 9.29, 95% CI 1.72 to 50.14) and probable mycological cure (RR 3.15, 95% CI 1.93 to 5.12).
  • Oral vs. Topical Treatments: Oral treatments like terbinafine and itraconazole provided higher cure rates and better outcomes but with increased safety risks, while newly approved topicals like efinaconazole and tavaborole showed superior effectiveness compared to previous topical treatments and placebo.
  • Efinaconazole: Slightly higher risk of adverse events (RR 1.10, 95% CI 1.01 to 1.20), with common side effects being dermatitis and vesicles.
  • Tavaborole 5% Solution: Increased risk of adverse events, specifically application site reactions (RR 3.82, 95% CI 1.65 to 8.85).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Jublia (efinaconazole) prescribing infromation.2022Bausch Health US LLC, Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effect of onychomycosis and treatment on patient-reported quality-of-life outcomes: A systematic review.2021Journal of the American Academy of Dermatology
Topical and device-based treatments for fungal infections of the toenails (review). 2020Cochrane Database of Systematic Reviews
Antifungal drug use for onychomycosis.2019American Journal of Therapeutics

Clinical Practice Guidelines

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