The Medicines Company announced 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, or 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 endpoints required by the FDA and the later endpoint required by the European Medicines Agency. The efficacy was similar in the overall population and in those patients with microbiologically confirmed MRSA infections.
- Pharmaceuticals & Drug Trials