Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
Loceryl (Roche Products)
5% nail lacquer in 5 mL
Indication: fungal infections
Amorolfine is a member of a new class of antifungal drugs. It interferes with sterol biosynthesis and therefore the fungal cell membrane. The effect may be fungistatic or fungicidal.
The nail lacquer can be applied once or twice a week to nails infected by moulds, yeasts or dermatophytes. Treatment may have to continue for many months, particularly when the toenails are involved. There are limited data on the long term use of amorolfine.
In general, amorolfine is effective, although not all patients, especially those with onychomycosis, will respond. It is unknown how effective the nail lacquer is for patients with infections involving more than 80% of the nail, as this group were excluded from some studies. The nail lacquer must be applied by a certain method. To assist the patient, the lacquer is supplied in a kit containing cleaning pads, spatulas and nail files.
Some of the amorolfine applied is absorbed, particularly through the skin; however, the majority of adverse effects occur at the site of application. The drug has been given a B3 classification for use in pregnancy.
Overseas information suggests that amorolfine may be a relatively expensive drug. There is, therefore, a need for clinical studies to compare amorolfine with other antifungal drugs.