Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies

Abstract

Purpose: The role of topical antifungal agents in the long-term management of toenail onychomycosis is not well established. The current study evaluated durability of clinical benefit of tavaborole topical solution, 5%, for the treatment of toenail onychomycosis.

Methods: We conducted a pooled analysis of 8-week, post-study follow-up (PSFU) data from two phase 3, randomized controlled trials in a subset of patients who experienced complete or almost clear nail (CN) at the end of treatment (week 52); 48 weeks of treatment with once-daily tavaborole compared with placebo in adults with distal subungual onychomycosis was evaluated at week 60. Complete cure (completely CN plus negative mycology) of the target great toenail and treatment success (<10% nail involvement plus negative mycology) were evaluated at week 52 versus week 60.

Results: Of the 62 patients who completed the PSFU, complete cure was higher in the tavaborole-treated group versus the vehicle control group (28.6% vs. 7.7%). Additionally, treatment success was 53.1% for the tavaborole group versus 23.1% in the vehicle group. Small sample size entering the PSFU limited robust statistical analysis.

Conclusion: Tavaborole topical solution, 5%, appears to provide durable clinical benefit, making it an attractive long-term treatment option for dermatophyte-associated onychomycosis of the toenail.

Keywords:

• Antifungal agents
• AN-2690
• long-term follow-up
• tavaborole
• tinea unguium

Acknowledgements

Writing and editorial assistance was provided by Nick Watson, PhD, and ApotheCom, LLC, Yardley, PA. This assistance was funded by Sandoz Inc.

Disclosure statement

The authors are fully responsible for the content, editorial decisions and opinions expressed in the current article. No author received an honorarium related to the development of this manuscript. A. K. Gupta has received consulting fees, advisory board honoraria and/or research grants (as a primary investigator) from Sandoz Inc., Valeant Canada, Moberg Pharma, and Almirall. S. Hall is a Director of Medical Affairs at Sandoz Inc. At the time of the study, L. T. Zane was an employee and shareholder of Anacor Pharmaceuticals Inc. and is now no longer employed by, or a shareholder of, Anacor. S. R. Lipner has received advisory board honoraria from Sandoz Inc. P. Rich has received advisory board honoraria and research grants (as primary investigator) from Anacor, Valeant, Biomet and Moberg.

Additional information

Funding

Writing assistance was funded by Sandoz Inc.