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Positive Phase III Results for Dalbavancin in Patients With Skin Infections
Antibiotic drug noninferior to vancomycin (Feb. 25)
Positive results have been reported from a phase III study of dalbavancin (Durata Therapeutics), which is under investigation for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Preliminary data show that dalbavancin achieved its primary endpoint of non-inferiority at 48 to 72 hours after initiation of therapy, as determined by the cessation of lesion spread as well as by the resolution of fever.
Researchers compared two intravenous doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen had an option to switch to oral linezolid after 3 days of vancomycin treatment. In addition, the trial assessed as a secondary outcome measure the non-inferiority of the clinical response at the end of treatment in clinically evaluable patients. Dalbavancin also achieved this secondary endpoint.
The Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response 2 (DISCOVER 2) study was a phase III randomized, double-blind, double-dummy trial involving 739 patients in the U.S., Europe, Asia, and South Africa.
An early response (within 48 to 72 hours after initiation of treatment) was achieved by 76.8% (285/371) of the dalbavancin group compared with 78.3% (288/368) of the vancomycin/linezolid group. Moreover, 87.6% (325/371) of dalbavancin-treated patients showed a reduction in lesion size of more than 20% compared with 85.9% (316/368) of those treated with vancomycin and linezolid.
The drug-related treatment-emergent adverse event rates were 12.2% for dalbavancin and 10.1% for vancomycin/linezolid. The most commonly reported adverse events for dalbavancin included nausea, diarrhea, vomiting, pruritus, and headache. Rates of discontinuation due to treatment-emergent adverse events were 2.4% and 1.9% for dalbavancin and vancomycin/linezolid, respectively.
Source: Durata Therapeutics; February 25, 2013.