Single Dalvance Dose As Effective for ABSSSI in Phase 3 Trial

Actavis announced results for its Phase 3 DUR001-303 study of single dose Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).

DUR001-303 was a randomized, double-blind, double-dummy trial conducted in 698 patients comparing single dose Dalvance to the approved two doses of Dalvance given one week apart.

Preliminary data demonstrated that the 1500mg single-dose of Dalvance achieved its primary endpoint of non-inferiority to the two-dose regimen 48–72 hours after initiation of therapy. This was determined by a decrease of > 20% in lesion area relative to the baseline measurement (81.4% vs. 84.2 % for the single dose vs. the two dose regimen, respectively; Difference -2.9; 95% CI: -8.5, 2.8). A similar proportion of patients with Staphylococcus aureus infections at baseline were clinical responders at the 48–72 hour time-point within each treatment group (122/137 [89.1%] in the single-dose treatment group vs. 124/145 [85.5%] in the two-dose treatment group).

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Dalvance is already indicated for the treatment of ABSSSI caused by susceptible Gram-positive microorganisms. Actavis plans to file a supplemental New Drug Application (sNDA) in the third quarter of 2015.

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