IV delafloxacin: Phase III data
Top-line data from the double-blind, international Phase III Study RX-3341-302 in about 660 patients with ABSSSI showed that 300 mg IV delafloxacin given every 12 hours met the FDA-defined primary endpoint of non-inferiority to vancomycin plus aztreonam in reducing lesion erythema area from baseline at 48-72 hours. Delafloxacin also met the secondary endpoint of non-inferiority to vancomycin plus aztreonam in the investigator assessment of signs and symptoms of infection at the follow-up visit on day 28, which is the EMA-defined endpoint. Melinta said patients in the comparator arm received vancomycin plus aztreonam, but were able to discontinue aztreonam if results of initial cultures showed that the pathogen was Gram positive, which was the case in the “majority” of patients. Delafloxacin was well tolerated. ...