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Durata Therapeutics Achieves Target Enrollment In Phase III

Durata Therapeutics (NASDAQ: 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The protocol design of DISCOVER 1 is consistent with FDA Draft Guidance for Developing Drugs for Treatment of abSSSI.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).

Posted-In: News FDA

 

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