Durata Therapeutics today announced supportive, retrospective data from a previously completed global, Phase 3 study of the Company’s lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide. As reported in a poster presentation titled, “Dalbavancin vs Linezolid for Treatment of Acute Bacterial Infections of the Skin: A Comparison of Early and Standard Outcome Measures in Study VER001-9”, a reanalysis of data from that Phase 3 study demonstrated that clinical efficacy associated with dalbavancin was again similar to linezolid, in these analyses based on both resolution of fever and cessation of spread of the lesion within a 48- to 96-hour period after the start of therapy. Recently, the Food and Drug Administration (FDA) issued new draft guidance establishing that antibiotic effectiveness be assessed between 48 and 72 hours following initiation of therapy.
