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April 13, 2007 -- The FDA today approved a new prescription antibacterial ointment called Altabax to treat impetigo.
Impetigo is a highly contagious skin infection caused by bacteria. It's most common among children and is usually spread through physical contact with someone who has impetigo, or from sharing clothes, bedding, towels, or other objects.
Altabax is for patients who are at least 9 months old and have impetigo due to the common bacteria Staphylococcus aureus or Streptococcus pyogenes, states GlaxoSmithKline, which makes Altabax.
Altabax represents the first new class of prescription topical antibacterials to be approved by the FDA in nearly 20 years, notes GlaxoSmithKline.
Altabax is used twice daily for five days. Other prescription topical antibiotics are used as much as three times daily for up to 12 days, says GlaxoSmithKline.
The FDA approved Altabax based on effectiveness data from a study of 210 adults and children with impetigo.
A total of 139 patients received Altabax. The others patients got an ointment containing no medicine (placebo).
After five days of treatment, success was more common in the Altabax group than in the placebo group, according to GlaxoSmithKline.
The FDA says it also reviewed safety data on approximately 2,000 Altabax-treated adults and children who were at least 9 months old and another 1,000 patients who used other antibiotics or a placebo.
The most common Altabax-related adverse event was irritation at the application site. That problem affected less than 2% of the patients, notes the FDA.