Medimetriks Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 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. "Given the positive efficacy data, concerns about increasing MRSA rates and emerging resistance to current treatments, Xepi™ has the potential to offer patients a safe and effective option that could fulfill an important unmet medical need."
The approval of Xepi 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 aged 2 months and older with impetigo. Xepi 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 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). MRSA is a significant public health concern in the US and there is a need for new, effective antibiotics to help treat this resistant organism. In the pivotal trials, Xepi was also found to be negligibly absorbed, safe and well-tolerated in pediatric and adult patients aged 2 months and older.
Medimetriks licensed exclusive U.S. commercialization rights to Xepi from Ferrer, a privately held Spanish pharmaceutical company, in March 2014.