FDA Approves Ozenoxacin Cream for Impetigo

Troy Brown, RN

Disclosures

December 15, 2017

The US Food and Drug Administration (FDA) has approved ozenoxacin cream (Xepi Cream, Medimetriks Pharmaceuticals Inc) 1% for impetigo in patients aged 2 months and older. Ozenoxacin cream is a quinolone antimicrobial drug applied to the skin twice daily for 5 days.

"Impetigo is a highly contagious bacterial skin infection that affects millions of children and adults in the United States each year," Theodore Rosen, MD, professor of dermatology at Baylor College of Medicine, Houston, Texas, said in a news release.  "Given the positive efficacy data, concerns about increasing MRSA [methicillin-resistant Staphylococcus aureus] rates and emerging resistance to current treatments, Xepi has the potential to offer patients a safe and effective option that could fulfill an important unmet medical need."

Impetigo, the most frequent bacterial skin infection, is responsible for approximately 10% of skin ailments seen in pediatric clinics in the United States.

The approval follows consideration of data from two phase 3 multicenter, randomized, double-blind, vehicle-controlled trials that included 877 patients aged 2 months and older with impetigo. Ozenoxacin was superior to placebo on the prespecified clinical and bacteriologic endpoints in those studies.

At the end of treatment, 90.8% of patients who underwent treatment with ozenoxacin achieved bacterial success, compared with 69.8% of those in the placebo group (P < .001). The researchers defined bacterial success as "bacterial eradication or presumed eradication." Ozenoxacin demonstrated "excellent antibacterial activity" against S aureus (including MRSA) and Streptococcus pyogenes.

Ozenoxacin was safe and well tolerated in children and adults aged 2 months and older, with negligible absorption.

"We believe that Xepi has the potential to disrupt traditional impetigo treatment since patients may present with infections resistant to current topical therapies. The ability to cover both sensitive and resistant bacteria, such as MRSA, offers the potential to reduce treatment failures and enhance patient care," Bradley Glassman, chairman and chief executive officer of Medimetriks, said in the news release.

"We look forward to the launch of Xepi in the first quarter of 2018," Glassman added.

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