BioCentury
ARTICLE | Clinical News

MDCO's ABSSSI compound meets in second Phase III

July 3, 2013 1:01 AM UTC

The Medicines Co. (NASDAQ:MDCO) said a single dose of IV oritavancin met the FDA-defined and EMA-defined primary endpoints of non-inferiority to twice-daily vancomycin for 7-10 days in the 1,005-patient Phase III SOLO II trial to treat acute bacterial skin and skin structure infection (ABSSSI). Specifically, oritavancin was non-inferior to vancomycin on the FDA-defined endpoint of the proportion of patients with an early clinical response, defined as cessation of spread of the lesion, absence of fever and no rescue antibiotics at 48-72 hours after treatment start (80.1% vs. 82.9%). Oritavancin was also non-inferior to vancomycin on the EMA-defined endpoint of the proportion of patients with investigator-assessed clinical cure at 7-14 days after the end of treatment (82.7% vs. 80.5%). The threshold for non-inferiority for both endpoints was 10%.

Last December, The Medicines Co. reported data from the identical Phase III SOLO I trial showing that oritavancin met the FDA- and EMA-defined primary endpoints of non-inferiority to vancomycin in 968 patients with ABSSSI. The company has an SPA from FDA for both trials (see BioCentury Extra, Dec. 20, 2012). ...