It is now approved for use as a single dose administered as a 30 minute intravenous (IV) infusion for the treatment of acute bacterial skin and skin structure infections (ABSSSI), caused by designated Gram-positive bacteria in adults. This includes infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
The FDA approval was based on data from DUR001-303, a Phase 3 study that compared a single 1500mg dose of Dalvance with the 2-dose regimen of 1000mg, followed by 500mg one week later. The results showed that the 1500mg single dose met its primary endpoint of non-inferiority to the 2-dose regimen at 48–72 hours after treatment initiation, as determined by a decrease of ≥20% in lesion area relative to the baseline measurement (81.4% vs. 84.2%, respectively, difference -2.9, 95% CI: -8.5, 2.8).
Dalvance, a 2nd-generation, semi-synthetic lipoglycopeptide antibiotic, is the first 30-minute, single-dose option for ABSSSI. It was initially approved in May 2014 for the treatment of adults with ABSSSI.
For more information call (800) 433-8871 or visit Dalvance.com.