Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Galderma International S.A.S., Tour Europlaza, La Défense 4, 20 Avenue André Prothin, France
Pharmacotherapeutic group: OTHER ANTIFUNGALS FOR TOPICAL USE
ATC code: D01AE16
CURANAIL is a topical antifungal. The active ingredient, amorolfine, a morpholine derivative, belongs to a novel chemical class of antifungals. The fungistatic and fungicidal effects are mediated through impairment of the fungal cell membrane and mainly affect sterol biosynthesis.
The ergosterol content is reduced. Accumulation of atypical sterols results in morphological modifications of the cell membranes and organelles, inducing lysis of the fungal cell.
Amorolfine has a broad antifungal spectrum. It is highly effective against the usual and occasional causative agents of onychomycosis:
Yeasts:
Candida albicans and other species of Candida
Dermatophytes:
Trichophyton rubrum, Trichophyton interdigitale and Trichphyton mentagrophytes, other species of Trichophyton
Epidermophyton floccosum
Microsporum
Moulds:
Scopulariopsis
Dematiacea (black fungi):
Hendersonula, Alternaria, Cladosporium
Less sensitive species:
Aspergillus, Fusarium, Mucorales
Amorolfine, in nail lacquer form, penetrates and diffuses through the nail plate and is thus able to eradicate poorly accessible fungi in the nail bed.
The systemic absorption of the active ingredient is negligible. Plasma concentrations remain lower than the limit of detection, even after one year of use.
Oral thirteen-week studies have been performed with up to 60 mg/kg bw/day or 26‑week studies with a dosage of up to 40 mg/kg bw/day in rats and dogs. Keratodermia and dermatitis like lesions of the skin, hyperkeratosis of mucous membrane and the transition skin/mucous membrane have been observed.
Reproductive toxicology studies showed evidence of teratogenicity, embryotoxicity and foetotoxicity in laboratory animals but these effects were observed at exposure far exceeding human exposure indicating no anticipated risk for pregnant women.
Amorolfine potential genotoxicity has been tested in vitro and in vivo. No genotoxic potential has been observed.
No carcinogenicity studies have been conducted.
Topical administration of amorolfine nail lacquer in animals has shown dermal toxicity under occlusive conditions. Amorolfine nail lacquer did not induce sensitisation.
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