New oral and topical treatments for onychomycosis

Author:

R. Tsuboi

Author address:

Tokyo Medical University, TOKYO, Japan

Full conference title:

20th Congress of the International Society for Human and Animal Mycology, Amsterdam, the Netherlands

Date: 23 July 2018

Abstract:

With an aging demographic worldwide, the prevalence of onychomycosis has been on the rise. It is well-known that onychomycosis is resistant to conventional systemic and topical treatments. Developing a new therapeutic strategy and agent is crucial to curing dermatophyte infections and improving patient’s QOL. One oral and two topical formulations have recently been approved for clinical use. The first, efinaconazole, a triazole derivative with low affinity for keratin protein, was synthesized by Kaken Co. in 1991 and developed in Canada by Valenant Co. An efinaconazole 10% solution (Jublia R  and Clenafin R ) was launched in Canada, US, Japan, and Korea since 2013. Two phase III studies enrolled patients with toenail onychomycosis with 20–50% clinical involvement. The patients were treated without debridement once daily for 48 weeks. The complete cure rate (clinical cure plus negative KOH) at week 52 was 17.8% and 15.2% (placebo: 3.3% and 5.5%) (P < 0.001), respectively. Luliconazole, an imidazole derivative developed in Japan by Nihon Nohyaku Co. in 1995, has a very low MIC against Trichophyton rubrum and T. mentagrophytes (0.00029 μg/mL and 0.00080 μg/mL, respectively). A luliconazole 5% solution (Luconac R ) was developed by Pola Pharma and Sato Pharmaceutical and launched in Japan in 2016. A phase III study was conducted with patients with toenail onychomycosis with 20–50% clinical involvement. The patients were treated once daily for 48 weeks. The complete cure rate at week 48 was 14.9% (29/194 subjects) versus vehicle 5.1% (5/99subjects) (P = 0.012). Ravuconazole, a triazole derivative synthesized by Eisai Co., has a low MIC90 for T. rubrum and T. mentagrophytes (0.06 μg/mL and 0.06 μg/mL, respectively), a longer terminal half-life, and less drug interaction. A prodrug, fosravuconazole l-lysine etanolate, is water-soluble and easily converted to active ravuconazole. A 100 mg capsule (Nailin R ) was developed for onychomycosis treatment by Sato Pharmaceutical and launched in Japan in 2018. In a phase III study enrolling patients with toenail onychomycosis with 25% or more clinical involvement, the patients were orally treated with one capsule daily for 12 weeks and observed at week 48. The complete cure rate was 59.4%, (60/101 subjects) versus 5.8% (3/52 subjects) for the vehicle (P < 0.001), and the negative KOH rate was 82% and 20% (P < 0.001), respectively. The side effects were tolerable. Systemic treatment is the first line treatment for onychomycosis, but topical antimycotics are useful for mild DLSO and SWO patients and for the patients who have limited indications for systemic treatment. The variety and combination of treatments will doubtless further improve the cure rate for onychomycosis.

Abstract Number: S5.2d

Conference Year: 2018

Link to conference website:

Link Conference abstract: 

ISHAM 2018

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