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Medicines Co Announces Positive Results For Solo II Trial Of Oritavancin In Treatment Of Acute Bacterial Skin And Skin Structure Infections


Tuesday, 2 Jul 2013 07:00am EDT 

The Medicines Company announced results for its Phase 3 SOLO clinical trial program 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). SOLO I and SOLO II are identical multicenter, double-blind, randomized clinical trials. The Company reported positive SOLO I results in December 2012 and report similar positive SOLO II results. In SOLO II, all protocol-specified primary and secondary efficacy endpoints were met. SOLO II demonstrated oritavancin to be non-inferior to vancomycin for both US and European regulators' required efficacy endpoints. All pre-specified endpoints were achieved, both for the Early Clinical Evaluation (ECE) (or 48-72 hour) required by the US Food and Drug Administration (FDA) and for the later Post Therapy Evaluation (PTE) (7-14 days after end of treatment) required by the European Medicines Agency (EMA). In SOLO II, adverse events were reported with similar frequencies on oritavancin and vancomycin. 

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1 Oct 2014