FRIDAY, April 13 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new molecular entity, Altabax (retapamulin ointment), for the treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in patients 9 months of age and older.
Altabax is a pleuromutilin, a class of drug that inhibits protein synthesis in bacteria by binding to the 50S sub-unit of ribosomes.
Manufactured by GlaxoSmithKline, the antibiotic is applied twice daily for a five-day period. Approval was based on clinical trials involving about 2,000 adults and children, who were compared to 1,000 patients treated with a placebo or other antibiotics.
The clinical success rate was 85.6 percent compared with 52.1 percent for placebo. About 1.4 percent of patients experienced skin irritation, which was the most common side effect.
"Altabax provides clinicians with a convenient new means to effectively fight the bacteria that cause impetigo through an effect that is different from other antibiotics," said Stan Block, M.D., president of Kentucky Pediatric and Adult Research Inc., in a statement issued by GlaxoSmithKline. "In vitro, this new topical antibiotic has shown a low potential for the development of resistance, possibly because it works in a unique manner compared to other antibiotics."
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