Oral delafloxacin: Phase III data

Top-line data from the double-blind, international Phase III RX-3341-303 trial in 850 patients with ABSSSIs showed that IV-to-oral Baxdela met the FDA-defined primary endpoint of non-inferiority to standard of care (SOC) IV vancomycin plus aztreonam in the proportion of patients with a >=20% reduction in lesion erythema area compared to baseline at 48-72 hours after the start of treatment (83.7% vs. 80.6%). The non-inferiority margin was 10%. IV-to-oral Baxdela also met the EMA-defined endpoint of non-inferiority to SOC in complete cure rate based on an investigator assessment of signs and symptoms of infection at the follow-up visit on day 14 (57.7% vs. 59.7%). Both IV and oral Baxdela were well tolerated. Patients received SOC or 300 mg IV Baxdela every 12 hours for 3 days followed by 450 mg oral Baxdela every 12 hours for 2-11 days based on physician’s judgment. The trial has an SPA from FDA. ...