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news.Durata Therapeutics has begun enrollment in Phase 3 study, Discover-2 of dalbavancin, an intravenous (IV) lipoglycopeptide to treat acute bacterial skin and skin structure infections (abSSSI).
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Discover-2 is a randomized, double-blind, double-dummy study conducted in patients randomized to vancomycin allowed to switch to oral linezolid after three days of IV vancomycin therapy.
The study evaluated the efficacy and safety of dalbavancin in comparision to vancomycin.
The company has reached 20% patient enrollment in the Discover-1 study.
Discover-1 and Discover-2 are being conducted under separate Special Protocol Assessments (SPA) in accordance with the US Food and Drug Administration (FDA).
About 556 patients are expected to be enrolled for each study, making a total of 1112 patients.