Drug updated on 9/4/2024
Dosage Form | Solution (topical: 5%) |
Drug Class | Oxaborole antifungals |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
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Summary
- Kerydin (tavaborole) is indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Tavaborole (5% solution): Achieved a complete cure with a relative risk (RR) of 7.40 (95% CI 2.71 to 20.24) and mycological cure with an RR of 3.40 (95% CI 2.34 to 4.93), based on evidence from 1198 participants.
- Efinaconazole (10% solution): Showed effectiveness in complete cure (RR 3.54, 95% CI 2.24 to 5.60; 1716 participants), clinical cure (RR 3.07, 95% CI 2.08 to 4.53; 1655 participants), and mycological cure (RR 2.31, 95% CI 1.08 to 4.94; 1716 participants). 5. 1064-nm Nd Laser: Demonstrated little or no difference in mycological cure at 52 weeks (RR 1.04, 95% CI 0.59 to 1.85; 2 studies, 85 participants). Complete cure was not measured.
- Tavaborole: Tavaborole has a higher risk of adverse events, particularly application site reactions, with a risk ratio (RR) of 3.82 (95% CI 1.65 to 8.85) in 1186 participants (moderate-quality evidence).
- Comparison with Other Drugs: Ciclopirox 8% lacquer may increase adverse events like application reactions, rashes, and nail alteration (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence). Efinaconazole 10% solution has a slightly higher risk of adverse events such as dermatitis and vesicles (RR 1.10, 95% CI 1.01 to 1.20; high-quality evidence). P-3051 (Ciclopirox 8% Hydrolacquer) shows no difference in adverse event risk (RR 0.60, 95% CI 0.19 to 1.92; low-quality evidence). Luliconazole 5% solution shows little or no difference in adverse events (RR 1.02, 95% CI 0.90 to 1.16; low-quality evidence).
- Device-Based Treatments: The 1064-nm Nd laser has uncertain differences in adverse events (very low-quality evidence).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Kerydin (tavaborole) Prescribing Information. | 2018 | Pfizer Labs, Division of Pfizer Inc., NY, NY 10017 |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
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 |