The drug is indicated for impertigo caused by susceptible strains of staphylococcus aureus or streptococcus pyogenes, the two most common types of bacteria in this kind of infection, in patients nine months of age and older. The drug is to be used twice daily for a five-day period. Other prescription topical antibacterials are used as much as three times daily for up to 12 days.
In making its decision, the FDA reviewed phase III data examining the safety and efficacy of Altabax versus placebo ointment in the treatment of impetigo, as well as additional safety data from other clinical studies.
The findings showed that after five days of treatment, the rates of clinical success, defined as response of impetigo at end of therapy wherein no further antibacterial treatment was needed, were greater in the Altabax group at 85.6% than in the placebo group where the rate of clinical success was 52.1%.
According to GlaxoSmithKline the active ingredient in Altabax has shown no target-specific cross-resistance to other established classes of antibacterials, because currently no other antibacterials use the exact same mode of action.