Medimetriks Pharmaceuticals, Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ozenoxacin cream, 1%, a novel, non-fluorinated quinolone for the treatment of impetigo.  

Medimetriks licensed exclusive U.S. commercialization rights to ozenoxacin from Ferrer, a privately held Spanish pharmaceutical company, in March 2014 and announced the completion of the second successful Phase 3 pivotal trial in July 2015.   

Both Phase 3 pivotal studies demonstrated the superiority of ozenoxacin cream, 1%, applied topically twice daily for five days, versus placebo on both the clinical and bacteriological endpoints. In the studies, ozenoxacin demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3-4), and showed excellent antibacterial activity against a broad range of bacteria.  The studies showed that ozenoxacin was safe and well tolerated in both the adult and pediatric populations aged 2 months and older. 

"Impetigo is a common, highly contagious bacterial skin infection that affects millions of children and adults in the United States each year," says Theodore Rosen, MD, Professor of Dermatology at Baylor College of Medicine in Houston, in a news release. "Given ozenoxacin's positive efficacy data and dermatologist's concerns about emerging resistance to current treatments, ozenoxacin has the potential to offer patients a safe and effective option that could fulfill an important need in dermatology."