|The Medicines Company Announces Positive Trial Results for Oritavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)|
Dec 20, 2012 (Marketwire via COMTEX) --The Medicines Company (
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 (48-72 hour) endpoints required by the U.S. Food and Drug Administration (FDA) and the later (7-14 days after end of treatment) endpoint required by the European Medicines Agency (EMA). The efficacy was similar in the overall population and in those patients with microbiologically confirmed MRSA infections.
Results in patients with confirmed MRSA infections
Overall, safety profiles were similar: 60.0% of patients on oritavancin and 63.8% of patients on vancomycin were reported to experience at least one adverse event. Fewer treatment emergent adverse events considered by investigators as related to study drug were reported among patients treated with oritavancin than vancomycin (22.8% vs. 31.4%; p value = 0.003). Results also included fewer skin and subcutaneous tissue adverse events (11.6% vs. 19.1%; p value = 0.001) among patients treated with oritavancin. Apart from these, adverse event rates were similar in both treatment arms, including rates of phlebitis.
The SOLO-1 trial design was agreed to through the Special Protocol Assessment process with the FDA and was also reviewed formally by the EMA. The trial is the first of two pivotal Phase 3 trials designed to support the filing of a New Drug Application in the United States as well as a Marketing Authorization Application (MAA) in Europe. The SOLO-1 and SOLO-2 trials are identical multicenter, double-blind, randomized clinical trials.
In the SOLO-1 trial, 968 ABSSSI patients were enrolled at 46 clinical sites worldwide. Treatment with a single intravenous dose of oritavancin was compared with 7-10 days of twice daily intravenous doses of vancomycin.
Commenting on the results, Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The Medicines Company, said: "These data 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 as efficacious as multiple days of vancomycin infusions. The safety profile also appears potentially advantageous over vancomycin. We believe that the SOLO-1 trial will become an important element in our efforts to secure regulatory approval for oritavancin in ABSSSI worldwide and we look forward to completing the enrollment of the identical SOLO-2 trial in the first half of 2013."
"Currently available intravenous treatment options for ABSSSI have limitations, including multiple-day dosing and treatment-limiting adverse events. The opportunity to manage patients with a single dose of oritavancin may be a next source of innovation. Furthermore, the microbiological spectrum and long half-life of oritavancin potentially provide avenues of investigation in even more severe infections, including those requiring prolonged periods of treatment," said Ralph Corey MD, Professor of Medicine and Infectious Disease at Duke University and Principal Investigator of the SOLO Trials.
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