Durata Therapeutics (NASDAQ: DRTX) today announced results from its QT study of the company’s lead product candidate, dalbavancin. Dalbavancin is currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The QT study data, presented at the 52
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), showed that in this study dalbavancin had no clinically significant impact on cardiac conduction.
The U.S. Food and Drug Administration (FDA) generally requires thorough QT studies for new chemical entities due to the risk of heart arrhythmias associated with some pharmaceutical products. The results observed in Durata’s definitive study are intended to satisfy the FDA’s requirements in this area. These data will be included in the company’s New Drug Application (NDA) for dalbavancin, which Durata anticipates submitting with the FDA in the first half of 2013.
For more information on this and four other Durata-related studies presented at ICAAC 2012, visit
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata is currently enrolling and dosing patients in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
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