Ferrer's Ozenoxacin shows superiority in Ph III impetigo trial

Privately-held Spanish drugmaker Ferrer Internacional says that it has successfully completed a Phase III clinical trial in adult and paediatric patients with impetigo involving Ozenoxacin formulated as a topical treatment for dermatological infectious conditions. The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea and Taiwan.

The study demonstrated the superiority of Ozenoxacin 1% cream, applied topically bid for five days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6-7). In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo as early as visit two (day 3-4). The trial also demonstrated that Ozenoxacin cream is safe and very well tolerated in the adult and paediatric population, which confirms the results of an absorption, tolerance and safety study in juveniles aged two months and above announced previously.

The trial, conducted at 27 centers in the USA, South Africa, Germany, Romania and Ukraine, involved 465 adult and paediatric patients aged two years and older with a clinical diagnosis of bullous or non-bullous impetigo.