Medicines Co Announces Positive Trial Results for Oritavancin

Medicines Co announced the results for its SOLO-1 Phase 3 clinical trial of oritavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). All protocol-specified primary and secondary efficacy endpoints of the SOLO-1 trial were met. Oritavancin was shown to be non-inferior to vancomycin in the efficacy analyses for the early clinical evaluation (48-72 hour) endpoints required by the U.S. Food and Drug Administration (FDA) and the later (7-14 days after end of treatment) endpoint required by the European Medicines Agency (EMA). The efficacy was similar in the overall population and in those patients with microbiologically confirmed MRSA infections.