The FDA has approved for the treatment of impetigo, ozenoxacin cream, 1% (Xepi, Medimetriks Pharmaceuticals, Inc.) In patients 2 months of age and older. The product is applied topically twice daily for five days.
In the U.S., impetigo is assessed to represent around 10% of skin problems observed in pediatric centers and is considered as the most widely recognized bacterial skin infection. Dr. Theodore Rosen, Professor of Dermatology at Baylor College of Medicine said, “Impetigo is a highly contagious bacterial skin infection that affects millions of children and adults in the United States every year”.
The approval depends on a clinical development program that includes the outcomes of two stage 3, multicenter, randomized, double-blind, vehicle-controlled trials that enrolled 877 subjects ages 2 months and older with impetigo.
Xepi exhibited 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 utilizing Xepi versus 69.8% for placebo (P < 0.0001) at the end of treatment.
Xepi demonstrated excellent antibacterial activity against S. aureus and S.pyogenes, including methicillin-safe S. aureus (MRSA). In the essential trials, Xepi was also observed to be negligibly absorbed, safe, and well tolerated in pediatric and adult patient’s ages 2 months and older.
Medimetriks licensed exclusive U.S. commercialization rights to Xepi from Ferrer, a main, privately held Spanish pharmaceutical company, in March 2014.
Xepi, a new chemical entity, to a new generation of non-fluorinated quinolones. In two Phase 3 pivotal examinations, Xepi indicated positive efficacy and appeared to be safe and well tolerated in both adult and pediatric populaces aged 2 months and older.
What’s more, against pathologically significant bacteria and clinical isolates of organisms Xepi has shown excellent in vitro antibacterial action with developing resistance from methicillin-safe s. aureus (MRSA).
Xepi represents a novel and potentially important treatment for the topical treatment of impetigo.