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Durata Therapeutics
DRTX today announced that it has completed its
target enrollment for DISCOVER 1 (“Dalbavancin for Infections of the Skin
COmpared to Vancomycin at an Early Response”), one of two ongoing, global,
Phase 3 clinical trials of Durata's lead product candidate, dalbavancin, under
investigation for the treatment of acute bacterial skin and skin structure
infections (abSSSI).
DISCOVER 1 is a randomized, double-blind, double-dummy trial comparing the
efficacy of dalbavancin to a regimen of vancomycin for the treatment of
abSSSI. Researchers are comparing two intravenous doses of dalbavancin given
one week apart with twice daily vancomycin doses for 14 days. Patients
randomized to the vancomycin regimen have an option to switch to oral
linezolid after three days of vancomycin treatment.
The protocol design of DISCOVER 1 is consistent with FDA Draft Guidance for
Developing Drugs for Treatment of abSSSI. This pivotal study is being
conducted pursuant to a special protocol agreement with the U.S. Food and Drug
Administration, and is based on scientific advice provided by the European
Medicines Agency (EMA).
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