Efinaconazole topical solution (10%) for the treatment of onychomycosis in adult and pediatric patients

ABSTRACT

Introduction

Onychomycosis, a common nail disorder caused by fungal infection, can be managed pharmaceutically with oral or topical treatments. While oral treatments are often used first-line to treat nail infections, these systemic antifungals are not appropriate for all patients, and no oral treatments are approved for use in children in the USA. Given this need, topical antifungals were developed, which can be used as monotherapy or in combination with oral drugs.

Areas Covered

Efinaconazole 10% solution is an azole antifungal indicated for topical treatment of toenail onychomycosis in pediatric and adult patients. This qualitative literature review summarizes available chemical, pharmacological, efficacy, safety, and post-marketing surveillance data of efinaconazole 10% topical solution. Efinaconazole 10% has been shown to be safe and efficacious regardless of disease severity/duration at baseline; patient gender, ethnicity, or age (including pediatrics); or comorbidities such as diabetes or tinea pedis. Overall, efinaconazole is a safe and effective clinical option for the treatment and management of onychomycosis.

Expert Opinion

Efinaconazole is the first new antifungal approved for onychomycosis in 10 years in the USA. It has comparable efficacy to systemic antifungal agents such as itraconazole, and a favorable adverse events profile with minimal systemic exposure and no drug-drug interactions.

KEYWORDS:

• efinaconazole
• IDP-108
• KP-103
• antifungal
• azole
• topical
• lacquer
• onychomycosis
• pediatric

Article highlights

• Efinaconazole 10% topical solution is an azole antifungal indicated for use in patients aged 6 years and older for the topical treatment of onychomycosis of the toenail due to Trichophyton rubrum and Trichophyton mentagrophytes.

• Efinaconazole has higher in vitro activity than ciclopirox and itraconazole and comparable activity to amorolfine and terbinafine against dermatophytes.

• It has a low surface tension, water solubility, and low-keratin binding which enhances nail penetration and diffusion to the infection site through subungual and transungual spread.

• Efinaconazole is safe and effective in children and has been recently approved by the FDA for pediatric onychomycosis. It may be a promising treatment option in elderly, immunocompromised patients, onychomycosis patients with diabetes, and concurrent tinea pedis.

Acknowledgments

Medical writing support for a portion of the review article was provided by Lynn M. Anderson and Jacqueline Benjamin of Prescott Medical Communications Group (Chicago, IL), with financial support from Ortho Dermatologics (a division of Bausch Health US, LLC). Additional medical writing support was provided by Maanasa Venkataraman and Emma Quinlan of Mediprobe Research.

Author contributions

Both authors have substantially contributed to the conception and design of the review article and interpreting the relevant literature and have been involved in writing the review article or revised it for intellectual content.

Declaration of interest

Tracey C Vlahovic has served as investigator and speaker for Ortho Dermatologics; no payments were received. Aditya K Gupta has served as consultant, speaker, and investigator for Ortho Dermatologics; payments were received for consultation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

Financial support for this manuscript (medical writing provided by Prescott Medical Communications Group) was provided by Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.