Adis drug profile - Dalbavancin

Dalbavancin is a semisynthetic glycopeptide antibacterial agent that is active against Gram-positive bacteria associated with complicated skin and skin structure infections (cSSSIs). It is administered as a two-dose regimen intravenously infused over 30 minutes once weekly. The efficacy of dalbavancin (1000 mg on day 1 and 500 mg on day 8) has been examined in two randomized controlled trials in adults with cSSSIs. In each study, the primary efficacy measure was clinical success at the test-of-cure or follow-up visit in clinically evaluable patients. In a randomized, controlled, double-blind, multinational, phase 111 trial, dalbavancin was noninferior to linezolid, with clinical success rates of 88.9% and 91.2%. In a randomized, open-label, multicentre, phase 11 trial, clinical success rates were 94% with dalbavancin and 76% with comparator antibacterials. Dalbavancin was generally well tolerated by adult patients with cSSSIs, with most adverse events being of mild or moderate severity.