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.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on November 9, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
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