FDA Greenlights NDA for New Impetigo Treatment

The U.S. Food and Drug Administration (FDA) has accepted Medimetriks Pharmaceuticals, Inc.'s New Drug Application (NDA) for their novel impetigo treatment, ozenoxacin cream, 1%.

Ozenoxacin cream is a non-fluorinated quinolone.  The Prescription Drug User Fee Act (PDUFA) date for the completion of FDA's review is June 22, 2017.

In the U.S., impetigo is estimated to account for approximately 10 percent of the skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.  The impetigo market has few contemporary treatments available and generates more than 8 million prescriptions annually, according to information in the news release announcing the NDA acceptance.

Medimetriks licensed exclusive U.S. commercialization rights to ozenoxacin from Ferrer, a 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 5 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 demonstrated that ozenoxacin was safe and well tolerated in both the adult and pediatric populations aged 2 months and older. 

Medimetriks submitted the ozenoxacin NDA to FDA in June, 2016.