Amorolfine. A review of its pharmacological properties and therapeutic potential in the treatment of onychomycosis and other superficial fungal infections.
Amorolfine is a structurally unique, topically active antifungal agent, which possesses both fungistatic and fungicidal activity in vitro. Its spectrum of in vitro activity includes dermatophyte, dimorphic, some dematiaceous and filamentous fungi, and some yeasts. In clinical trials, application of amorolfine 5% nail lacquer once or twice weekly for up to 6 months produced mycological and clinical cure in approximately 40 to 55% of patients with mild onychomycosis 3 months after cessation of therapy. Overall cure and improvement was observed in approximately 85 to 90% of patients with superficial dermatomycoses following treatment with amorolfine 0.25% cream for up to 6 weeks. However, few controlled, comparative trials are available for these different mycoses, and only small numbers of patients have been evaluated to date. Both preparations appear to be well tolerated; only minor localised adverse events have been reported in clinical trials. At present, the major potential indication for topical amorolfine appears to be onychomycosis. Within this clinical setting, amorolfine should be reserved for patients with mild infection without nail matrix involvement. Systemic therapy, however, remains essential for patients with severe intractable onychomycosis involving the nail bed. Evidence to date does not clarify whether the use of adjuvant topical amorolfine reduces the need for systemic therapy in patients with severely infected nails, or whether amorolfine is beneficial in individuals unresponsive to other treatment options.