The FDA has approved ozenoxacin cream, 1% (Xepi, Medimetriks Pharmaceuticals, Inc.) for the treatment of impetigo in patients 2 months of age and older. The product is applied topically twice daily for five days.
In the U.S., impetigo is estimated to account for approximately 10% of skin problems observed in pediatric clinics and is considered the most common bacterial skin infection. "Impetigo is a highly contagious bacterial skin infection that affects millions of children and adults in the United States each year," said Dr. Theodore Rosen, Professor of Dermatology at Baylor College of Medicine.
The approval is based on a clinical development program that includes the results of two phase 3, multicenter, randomized, double-blind, vehicle-controlled trials that enrolled 877 subjects ages 2 months and older with impetigo. Xepi demonstrated superiority versus placebo on the prespecified clinical and bacteriological endpoints when applied topically twice daily for five days.
Bacterial success, defined as bacterial eradication or presumed eradication, was achieved in 90.8% of patients using Xepi versus 69.8% for placebo (P < 0.0001) at the end of treatment. Xepi showed excellent antibacterial activity against S. aureus and S. pyogenes, including methicillin-resistant S. aureus (MRSA). In the pivotal trials, Xepi was also found to be negligibly absorbed, safe, and well tolerated in pediatric and adult patients ages 2 months and older.
Medimetriks licensed exclusive U.S. commercialization rights to Xepi from Ferrer, a leading, privately held Spanish pharmaceutical company, in March 2014.
Xepi, a new chemical entity, belongs to a new generation of nonfluorinated quinolones.
Source: Medimetriks Pharmaceuticals, Inc.; December 14, 2017.