Foamix has completed a Phase II trial of minocycline foam in impetigo patients. Minocycline foam has shown to be highly effective against bacteria, including some multi-drug resistant strains (such as MRSA).
The randomised, double-blind study, conducted in paediatric patients with impetigo, was designed to assess the efficacy, safety and tolerability of two strengths of the Minocycline foam. Patients received the foam twice-daily for seven days; and they were checked again on day 14. Efficacy was demonstrated in both 1% and 4% strength doses in this randomised, double-blind, dose-ranging study enrolling 32 patients aged two to 15. Clinical response at the end of the treatment was 92 per cent and 100 per cent, respectively for the low or high doses; and all patients (100 per cent) showed success on day 14. In total, 80 per cent of the total patients cured or improved significantly after three days of treatment. Eight patients had MRSA and in all of them the bacterial infection was eradicated on day seven. No drug-related side-effects were recorder in any of the patients throughout the study.
Minocycline is an extremely unstable compound, which currently exists only in oral dosage forms. Foamix developed a stable, patient-friendly topical foam containing up to 4% minocycline. The topical administration of provides concentrated drug-delivery to the infected lesion site, and leads to rapid cure, whilst avoiding the side effects common in the oral minocycline treatment. With a twice-daily application, minocycline foam can lead to better patient compliance compared with other treatment options. In addition, foam is a user friendly dosage form, which spreads evenly and absorbs without rubbing.