Ferrer, a privately-held Spanish pharmaceutical company, has received approval to initiate phase III clinical trials of ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to conclude in the first quarter of 2013.
The randomized, placebo-controlled, parallel, double-blinded, superiority clinical study will compare ozenoxacin 1% cream versus a placebo. The trial will be conducted in about 465 patients up to two years old with a clinical diagnosis of non-bullous or bullous impetigo. Fifty centers will be participating in the study in the U.S., South Africa, Germany, Romania, India and Ukraine.
Ozenoxacin is a novel, second-generation, non-fluorinated quinolone antibacterial agent. Clinical efficacy has been demonstrated in a phase II dose-finding study in adult patients with secondarily infected traumatic lesions (SITLs). Topical ozenoxacin has proven to be safe and well tolerated in clinical trials involving almost 1,000 subjects, exhibiting no dermal absorption and no evidence of the adverse effects associated with topically formulated halogenated quinolones.
Ferrer’s ozenoxacin 1% topical cream is available for licensing worldwide, except in China, Japan and Taiwan.