FDA to Review Novel Topical Antibiotic for Impetigo
Medimetriks announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for ozenoxacin 1% cream for the treatment of impetigo.
The Company successfully completed two Phase 3 trials for ozenoxacin 1% cream in patients with impetigo. Both studies showed that ozenoxacin cream demonstrated superior bacteriological cure vs. placebo as early as day 3-4 of treatment, and showed excellent antibacterial activity against a broad range of bacteria, including clinical isolates of organisms with emerging resistance to quinolones and other topical antibiotics. Ozenoxacin was also found to have a tolerable safety profile in both adult and pediatric populations aged 2 months and older.
Ozenoxacin belongs to a novel generation of non-fluorinated quinolones under development for the potential treatment of a broad range of infectious dermatological conditions.
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