Ozenoxacin: A Novel Topical Quinolone for Impetigo.

Objective: To review the data supporting Food and Drug Administration (FDA) labeling of ozenoxacin and evaluate its place in therapy for impetigo.

Data Sources: A literature search was conducted using PubMed (1966 to May 2018) and Google Scholar (2000 to May 2018) with the search terms ozenoxacin, T-3912, and GF-001001-00. Other resources included clinicaltrials.gov , the manufacturing product label, and the FDA website.

Study Selection And Data Extraction: All relevant English-language data from abstracts, phase 1 to 4 studies, and review articles were included.

Data Synthesis: FDA labeling of ozenoxacin was based on 2 phase 3 studies conducted in patients 2 months of age and older. Ozenoxacin demonstrated efficacy and safety for use in bullous or nonbullous impetigo from Staphylococcus aureus or Streptococcus pyogenes as compared with placebo. The lack of systemic absorption results in minimal adverse drug reactions. Studies did not detect possible adverse events commonly associated with other quinolone antibiotics. Relevance to Patient Care and Clinical Practice: This topical quinolone has bactericidal activity against Gram-positive organisms, including methicillin-resistant Staphylococcus aureus. Ozenoxacin may have an expanded clinical role for the treatment of localized impetigo if resistance to current therapies increases significantly. However, ozenoxacin is unlikely to play a significant role in the treatment of impetigo in the foreseeable future, because of lack of direct comparative clinical efficacy data with currently recommended therapies and likely high cost.

Conclusions: Ozenoxacin, the first nonfluorinated quinolone, is a safe, topical treatment for impetigo in patients 2 months of age and older. Although clinical trials demonstrate efficacy compared with placebo, comparative trials to current treatment options are needed to identify its therapeutic use.