FAIRFIELD, N.J., Aug. 31, 2016 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ozenoxacin cream, 1%, a novel, non-fluorinated quinolone in development for the treatment of impetigo. The Prescription Drug User Fee Act (PDUFA) date for the completion of FDA's review is June 22, 2017.
Medimetriks licensed exclusive U.S. commercialization rights to ozenoxacin from Ferrer, a leading, 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 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.
"We are pleased that FDA has accepted the ozenoxacin NDA for review and, if approved, believe this new compound has the potential to be an important new treatment for patients suffering from impetigo," stated Bradley Glassman, Chairman & Chief Executive Officer of Medimetriks. "The acceptance of our NDA for review by FDA is a significant milestone for Medimetriks in achieving our goal of delivering innovation to Dermatology and addressing patients' unmet skin care needs."
Impetigo, a highly contagious bacterial skin infection commonly treated by Dermatologists and Pediatricians, most often affects infants, young children and those involved in close contact sports or living in enclosed environments. In the U.S., impetigo is estimated to account for approximately 10% 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.
Ozenoxacin cream, 1% belongs to a new generation of non-fluorinated quinolones. In two Phase 3 pivotal studies, ozenoxacin showed positive efficacy and that it was safe and well tolerated in both adult and pediatric populations aged 2 months and older. In addition, ozenoxacin has demonstrated excellent in vitro antibacterial activity against a broad range of pathologically relevant bacteria and clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics. Ozenoxacin represents a potentially important treatment option for the topical treatment of a broad range of infectious dermatological conditions.
Founded in 1959, Ferrer is a privately-held Spanish pharmaceutical company. It is present in more than 95 countries, with 24 international affiliates. Ferrer is active in the pharmaceutical, health, fine chemicals and food sectors; key areas for contributing to people's health and quality of life. The main therapeutic areas covered by Ferrer's pharmaceutical production are dermatology, cardiovascular, CNS, cancer, gastrointestinal, analgesics, bone metabolism, anti-infectives, immunology, diagnostics, OTC and dermocosmetics.
For more information, please visit: www.ferrer.com
About Medimetriks Pharmaceuticals, Inc.
Medimetriks Pharmaceuticals, Inc. is a leading independent branded Dermatology company with integrated development capabilities and robust commercial operations. The Company is dedicated to addressing unmet skin care needs through the development, licensing and commercialization of innovative prescription brands that advance patient care.
For more information, please visit: www.medimetriks.com
Senior Vice President, Brand Communication
Medimetriks Pharmaceuticals, Inc.
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Last updated on: 31/08/2016
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