Phase 3 Data From The Medicines Company's Oritavancin Solo Trials Featured at ICAAC Conference
DENVER, CO--(Marketwired - Sep 10, 2013) - The Medicines Company (
Oritavancin Phase 3 SOLO I and SOLO II trials are presented as part of poster presentations, with SOLO II as a late-breaking abstract by Ralph Corey MD, Professor of Medicine and Infectious Disease at Duke University and Principal Investigator of the SOLO trials.
Dr. Corey stated, "What is unique about this study is it is testing an antibiotic where the full course of treatment has been given to the patient through one administration. This study shows that a single 1200 mg dose of oritavancin was non inferior to 7 to 10 days of vancomycin in treating ABSSSI caused by gram-positive pathogens including methicillin-resistant Staphylococcus aureus, MRSA."
SOLO I and SOLO II were multicenter, double-blind, randomized trials, which evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including MRSA infections.
The combined SOLO studies represent the largest patient population (1,959 patients in modified intent-to -treat population) evaluating an anti-infective for the treatment of ABSSSI in controlled clinical trials and have assessed one of the largest subsets of patients with documented MRSA infection (405 patients).
In both SOLO trials, all protocol-specified primary and secondary efficacy endpoints were met. Oritavancin was demonstrated to be non-inferior to vancomycin for both required efficacy endpoints. All pre-specified endpoints were achieved, both for the Early Clinical Evaluation (ECE) (or 48-72 hour) required by the U.S. 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).
Dr. Corey stated, "The benefit of an early, definitive and aggressive treatment strategy in seriously infected patients warrants additional study in skin and other severe infections, including those requiring prolonged periods of treatment."
Safety profiles, measured at any point up to 60 days after treatment, were similar across treatment groups in SOLO I and SOLO II. The most common adverse events reported were nausea, headache, vomiting and diarrhea.
In addition to the SOLO I & II trial presentations, nine oritavancin-related abstracts will be presented in posters at the conference.
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