Actavis Plc: DALVANCE Phase 3 Trial Achieves Primary Endpoint - Quick Facts

(RTTNews) - Actavis plc (ACT) 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 caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus. Preliminary top-line data demonstrated the 1500 mg single-dose of DALVANCE achieved its primary endpoint of non-inferiority to the two-dose regimen at 48-72 hours after initiation of therapy. The trial also assessed the secondary outcome measures of clinical response at Day 14 as well as at Day 28. The single-dose of DALVANCE provided similar treatment efficacy to the two dose regimen in these secondary endpoints.

The company plans to file a supplemental New Drug Application with the data in the third quarter of 2015.