FDA to review new drug application for Medimetriks' ozenoxacin for impetigo

The FDA has accepted to review a new drug application for Medimetriks Pharmaceuticals’ ozenoxacin cream, 1%, for treating impetigo, according to a press release from the company.

Medimetriks licensed U.S. commercialization rights of Ozenoxacin cream, 1%, a novel, non-fluorinated quinolone from Ferrer, a Spanish pharmaceutical company, in 2014. The company announced the completion of a second phase 3 trial, in which ozenoxacin cream, 1%, demonstrated superiority to placebo in treating impetigo, in July 2015, according to the release.

In two phase 3 studies, ozenoxacin cream, 1%, applied topically twice dally for 5 days vs. placebo, demonstrated superiority on both clinical and bacteriological endpoints, according to the release. Superior bacteriological cure of ozenoxacin compared to placebo was demonstrated as early as day 4, according to the release.

In both adults and a pediatric population aged 2 months and older, ozenoxacin treatment was reported to be safe and well tolerated.

Impetigo is a highly contagious bacterial skin infection that most commonly affects infants, young children and those in close contact sports or living in enclosed environments, and is estimated to account for approximately 10% of skin problems observed in pediatric clinics in the United States, according to the release.

“We are pleased that the FDA has accepted the ozenoxacin [new drug application (NDA)] for review and, if approved, believe this new compound has the potential to be an important new treatment for patients suffering from impetigo,” Bradley Glassman, chairman and CEO of Medimetriks, stated in the release.

Medimetriks submitted the ozenoxacin NDA to the FDA in June; the Prescription Drug User Fee Act date for the FDA’s completion of the review is June 22, 2017, according to the release.

Reference: www.medimetriks.com