Cutanea Life Sciences Launches Xepi Cream

Cutanea Life Sciences, Inc. has launched Xepi™ (ozenoxacin) Cream, 1% for the treatment of impetigo in adult and pediatric patients two months of age or older. Xepi is a non-fluorinated topical quinolone indicated for the treatment of impetigo due to Staphylococcus aureusand/or Streptococcus pyogenes. It is applied topically twice daily for five days.

The availability by prescription of Xepi™marks the first novel topical prescription treatment for impetigo in the last 10 years.

Xepi has been shown to be active against most isolates of S. aureus (including methicillin-resistant isolates) and S. pyogenes, both in vitro and in clinical infections. In clinical trials, Xepi was found to be negligibly absorbed, safe, and well tolerated in pediatric and adult patients aged two months and older. 

“Impetigo is the leading bacterial skin infection seen by childhood health care providers. Crowding, heat and skin trauma are among the factors that lead to increased frequency,” says Lawrence A. Schachner, MD, Director of the Division of Pediatric Dermatology at the University of Miami Miller School of Medicine. “It had been a decade since a new topical antibiotic has been approved for this disorder. Therefore, Xepi is a very welcome and timely new addition to the armamentarium against certain strains of bacteria that may be resistant.”

"We are pleased to be commercializing Xepi in the US market, and making this unique advance in impetigo therapy available to health care professionals and parents to manage a troublesome skin disorder that afflicts several million young children each year,” says Robert J. Bitterman, Sr., CEO and President of Cutanea Life Sciences, Inc. "Xepi is consistent with our mission at Cutanea to provide topical, innovative therapies that address underserved patient needs in dermatology."