Ferrer begins second phase III study of Ozenoxacinin

Ferrer, a privately-held Spanish pharmaceutical company, announces that the first patient has been recruited into a second phase III trial of Ozenoxacin, formulated as a topical treatment for infectious dermatological conditions in adult and paediatric patients with impetigo. The study is scheduled to complete in Q1, 2015.

The multicentre, randomised, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in about 412 patients aged two months and over with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centres in the USA, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals

In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and over with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit. In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and paediatric populations.