Drug updated on 9/4/2024
Dosage Form | Solution (topical: 10%) |
Drug Class | Azole 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
- 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 Title | Year | Source |
---|---|---|
Jublia (efinaconazole) prescribing infromation. | 2022 | Bausch Health US LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Effect of onychomycosis and treatment on patient-reported quality-of-life outcomes: A systematic review. | 2021 | Journal of the American Academy of Dermatology |
Topical and device-based treatments for fungal infections of the toenails (review). | 2020 | Cochrane Database of Systematic Reviews |
Antifungal drug use for onychomycosis. | 2019 | American Journal of Therapeutics |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Therapeutic recommendations for the treatment of toenail onychomycosis in the US. | 2021 | Journal of Drugs in Dermatology |