The Food and Drug Administration (FDA) has approved Xepi (ozenoxacin cream; Medimetriks) for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.
Ozenoxacin, a quinolone antimicrobial drug, works by inhibiting the bacterial DNA replication enzymes, DNA gyrase A and topoisomerase IV. It has been shown to be bactericidal against S. aureus and S. pyogenes organisms.
The safety and efficacy of Xepi in the treatment of impetigo was evaluated in 2 multi-center, randomized double-blind placebo-controlled studies. Patients (N=723) ≥2 months old with an affected body surface area of up to 100cm2, and not exceeding 2% for patients aged 2 months to 11 years, were randomized to Xepi or placebo.
Clinical success was defined as no need for additional antimicrobial therapy of the baseline affected areas and absence or reduction in clinical signs and symptoms assessed at the end of therapy.
In both studies, a higher percentage of patients had clinical success in the Xepi-treated group compared to the placebo group (Trial 1: 34.8% vs. 19.2%; Trial 2: 54.4% vs. 37.9%). The success rates for Xepi were significantly different than placebo in both trials (Trial 1: P =.002; Trial 2: P =.001).
Xepi cream will be supplied in 10-, 30-, and 45g tubes; each gram of cream contains 10mg of ozenoxacin.
Medimetriks Pharmaceuticals, Inc. receives FDA approval for Xepi (ozenoxacin) cream, 1%, a novel topical antibiotic for impetigo [press release]. Fairfield, NJ; PR Newswire; December 14, 2017. Accessed December 19, 2017.
This article originally appeared on MPR