Success for Dalvance (dalbavancin) in DUR 001-303 Study for ABSSSI- Actavis

DUR 001-303 Study Meets Primary & Secondary Endpoints--- Actavis plc has announced positive top-line results for study DUR001-303, a phase III 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).

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 Dalvance (95% CI -6.0, 4.8). Actavis plans to file a supplemental New Drug Application (sNDA) with these data in Q3 2015.