BioCentury
ARTICLE | Clinical News

Ozenoxacin 1%: Phase III data

June 10, 2013 7:00 AM UTC

A double-blind, international Phase III trial in 465 patients aged 2 years and older with bullous or non-bullous impetigo showed that twice-daily topical ozenoxacin 1% cream for 5 days met the primary endpoint of improving both clinical and bacteriological endpoints by the end of therapy visit at day 6-7 vs. placebo cream. Ozenoxacin was well tolerated. The trial also included an active control arm in which patients received retapamulin 1% ointment, but data were not disclosed. Ferrer said the data, along with previously reported data from a safety and pharmacokinetic trial of the product, could form the basis of a regulatory filing for ozenoxacin in 2015, but declined to disclose details. ...