Impetigo: FDA has approved Retapamulin ointment


The FDA ( Food and Drug Administration ) has approved Altabax ( Retapamulin ointment ) for topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes, a skin infection caused by bacteria.

Altabax is indicated for use twice daily for a five-day period in patients nine months of age and older.

Impetigo is a highly contagious infection of the top layers of the skin and is most common among infants and children ages 2 to 6 years. Children are especially susceptible to infections because their immune systems are still developing. Impetigo spreads easily in schools and child care settings, as well as anywhere groups of people are in close contact.

In making its decision, the FDA reviewed Phase III data examining the safety and efficacy of Altabax twice daily for five days versus placebo ointment in the treatment of impetigo, as well as additional safety data from other clinical studies. 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 Staphylococcus aureus and Streptococcus pyogenes.
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 ( 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 ).

Altabaxis the first in a new class of antibacterials called pleuromutilins and is approved for the treatment of impetigo. By binding to a site on the 50S sub-unit of the bacterial ribosome, Altabax inhibits protein synthesis through an interaction with the ribosome that is unique to the pleuromutilin class. In vitro, the active ingredient in Altabax has shown no target-specific cross-resistance to other established classes of antibacterials, likely because currently no other antibacterials use the exact same mode of action.

The most common drug-related adverse event (AE) was application site irritation ( 1.4% ) in the group treated with Altabax.

Source: FDA, 2007

XagenaMedicine_2007



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