Durata Therapeutics Announces Completion of QT Study of Dalbavancin
September 11 2012 - 7:45AM
Business Wire
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 52nd 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
www.duratatherapeutics.com/media-center/publications.
About Dalbavancin
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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