The Food and Drug Administration has approved ozenoxacin cream 1% (Xepi), a topical antibiotic for treating impetigo attributable to Staphylococcus aureus or Streptococcus pyogenes in patients aged 2 months or older.

This is the first topical treatment for impetigo to be approved in more than 10 years, according to the press release from the manufacturer, Medimetriks Pharmaceuticals.

Approval was based on studies that included the results of two phase 3 randomized, double-blind, vehicle-controlled trials of 877 people aged 2 months or older, with impetigo. Ozenoxacin cream 1% or placebo was applied twice daily on the infected area for 5 days. At the end of treatment, 90.8% of those in the active treatment arms achieved bacterial success (defined as bacterial eradication or presumed eradication), compared with 69.8% of those on placebo (P less than .0001), according to the press release. Ozenoxacin cream was not readily absorbed, was well tolerated in adult and pediatric patients, and also showed antibacterial activity against methicillin-resistant S. aureus, according to the company.

Ozenoxacin is a quinolone antimicrobial. The prescribing information is available on the FDA website.

ilacy@frontlinemedcom.com

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