Tavaborole

(Kerydin®)

Tavaborole

Drug updated on 9/4/2024

Dosage FormSolution (topical: 5%)
Drug ClassOxaborole 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
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  • 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 TitleYearSource
Kerydin (tavaborole) Prescribing Information.2018Pfizer Labs, Division of Pfizer Inc., NY, NY 10017

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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