Actavis reports positive results from phase 3 study of single-dose DALVANCE for treatment of ABSSSI

Apr 25 2015

Actavis plc (NYSE: ACT) today announced positive top-line results for study DUR001-303, a phase 3 study comparing a single 1500 mg dose of DALVANCE with the same total dose given as two-doses one week apart, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).

Preliminary top-line data demonstrated the 1500 mg single-dose of DALVANCE achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48-72 hours after initiation of therapy, as 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) Similar proportions 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 and 124/145 (85.5%) in the two-dose treatment group).

"We are pleased with the results demonstrated in this trial. Single-dose dalbavancin has shown positive results for the treatment of serious skin infections and can be an important new treatment option for patients," said David Nicholson, Actavis Executive Vice President, Global Brands R&D.

In addition, the trial assessed the secondary outcome measures of clinical response at Day 14 (the EMA Primary Endpoint) as well as at Day 28. The single-dose of DALVANCE provided similar treatment efficacy to the two dose regimen in these secondary endpoints. 94.4% of patients in the single-dose DALVANCE arm and 94.0% of patients in the two-dose DALVANCE arm achieved clinical success at Day 14 (95% CI -3.5, 4.3). At Day 28, 84.5% of patients treated with a single-dose of DALVANCE achieved clinical success compared to 85.1% of those treated with the two-dose regimen of DALVANCE (95% CI -6.0, 4.8).

Actavis plans to file a supplemental New Drug Application (sNDA) with these data in Q3 2015.