Oritavancin(The Medicines Company) success Iin SOLO 11 trial for acute bacterial skin and skin structure infections

The Medicines Company has announced results for its Phase III 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 now reports 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 FDA and for the later Post Therapy Evaluation (PTE) (7-14 days after end of treatment) required by the European Medicines Agency . In SOLO II, adverse events were reported with similar frequencies on oritavancin and vancomycin.

The SOLO trials consistently show that a single dose of oritavancin given on presentation of a patient with ABSSSI to hospital can cure gram positive infections, including MRSA infections, and be at least as efficacious as multiple days of twice-daily vancomycin infusions.