The FDA has approved a topical cream for the treatment of impetigo in patients 2 months of age and older. Impetigo is considered to be the most common bacterial skin infection.
The approval of ozenoxacin (Xepi; Medimetriks Pharmacauticals) Cream, 1%, was based on a clinical development program that included the results of 2 phase 3 trials. According to the findings of the trials, ozenoxacin demonstrated superiority versus placebo on the pre-specified clinical and bacteriological endpoints when applied topically twice daily for 5 days. Bacterial success, defined as bacterial eradication or presumed eradication, was achieved in 90.8% of patients using ozenoxacin versus 69.8% for placebo (P<0.0001) at the end of treatment. The results of the trial also showed that treatment was well-tolerated in pediatric and adult patients aged 2 months and older.
The most common adverse reactions to treatment included rosacea and seborrheic dermatitis.
—Julie Gould
Reference:
Medimetriks Pharmaceuticals. Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi™ (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo [press release]. https://www.prnewswire.com/news-releases/medimetriks-pharmaceuticals-inc-receives-fda-approval-for-xepi-ozenoxacin-cream-1-a-novel-topical-antibiotic-for-impetigo-300571024.html. Published December 14, 2017. Accessed December 19, 2017.
