FDA approves Altabax for treatment of impetigo

June 5, 2007

Washington - The Food and Drug Administration (FDA) has approved GlaxoSmithKline's antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection, reports News-Medical.net.

Washington - The Food and Drug Administration (FDA) has approved GlaxoSmithKline's antibacterial Altabax for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, the two most common types of bacteria in this kind of infection, reports News-Medical.net.

According to GlaxoSmithKline, Altabax is the first new class of prescription topical antibacterials to win FDA approval in nearly 20 years. The drug is indicated for use twice daily for a five-day period in patients 9 months of age and older, a significantly shorter period than other prescription topical antibacterials, which are used as often as three times daily for up to 12 days.

In making its decision, the FDA reviewed phase 3 data examining the safety and efficacy of Altabax twice daily for five days versus placebo ointment in the treatment of impetigo. The randomized, double-blind, multi-center, placebo-controlled study enrolled a total of 210 adults and children with impetigo, of which 139 received topical Altabax. Culture-proven pathogens were seen in 82 percent of these patients, and the most common bacteria causing these infections were S. aureus and S. pyogenes.

The findings showed that after five days of treatment, the rates of clinical success were greater in the Altabax group (85.6 percent) than in the placebo group (52.1 percent). Microbiological success rates were also greater in the Altabax group (91.2 percent) than in the placebo group (50.9 percent). Altabax was generally well-tolerated throughout the study.