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Medimetriks submits new drug application to FDA for impetigo treatment
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Medimetriks Pharmaceuticals has submitted a new drug application to the FDA for the approval of ozenoxacin cream, 1% for treating impetigo, according to a press release.
“Impetigo is a common, highly contagious bacterial skin infection that affects millions of children and adults in the United States each year,” Theodore Rosen, MD, FAAD, professor of dermatology, Baylor College of Medicine, stated in the release. “Given ozenoxacin’s positive efficacy data and dermatologists’ concerns about emerging resistant to current treatments, ozenoxacin has the potential to offer patients a safe and effective option that could fulfill an important need in dermatology.”
Ozenoxiacin cream, 1%, a novel, non-fluorinated quinolone, was found to be superior to placebo in both clinical and bacteriological endpoints when applied daily for 5 days in two phase 3 pivotal studies. Ozenaoxacin also was found to be safe and well-tolerated in adults and pediatric patients aged 2 months and older, the release reported.
“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 large range of bacteria,” according to the release.
Exclusive U.S. commercialization rights to ozenoxacin were licensed by Medimetriks from Ferrer, a privately held Spanish pharmaceutical company, in March 2014, according to the release.
Reference: www.medimetriks.com