The Medicines Company announced the results from its Phase 3 SOLO 1 trial evaluating Orbactiv (oritavancin), an investigational intravenous antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). The data was published in the New England Journal of Medicine.
In the randomized, double-blind trial of 954 adults with acute bacterial skin and skin-structure infections, patients received either a single intravenous dose of oritavancin (1200mg) or intravenous vancomycin twice daily for 7–10 days. The single dose of oritavancin was found to be noninferior to vancomycin and the study met all of the efficacy endpoints:
- Cessation of spreading or reduction in lesion size, absence of fever, and no need for administration of a rescue antibiotic 48–72 hours after administration of oritavancin;
- Clinical cure 7–14 days after the end of treatment, as determined by a study investigator; and
- Reduction in lesion size of >20% 48–72 hours after administration of oritavancin.
Oritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive bacteria, including MRSA.
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