Date: 2015-04-24
Type of information: Results
phase: 3b
Announcement: results
Company: Actavis (Ireland)
Product: Dalvance® (dalbavancin)
Action
mechanism: peptide. Dalvance® (US)/ Xybalda® (EU) is a bactericidal lipoglycopeptide. Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall resulting in bacterial cell death.
Disease: Gram-positive acute bacterial skin and skin structure infections (ABSSSI)
Therapeutic area: Infectious diseases
Country: Bulgaria, Croatia, Estonia, Georgia, Hungary, Latvia, Romania, Russian Federation, Serbia, South Africa, Ukraine, USA
Trial
details: This phase 3b, double-blind, multicenter, randomized study aimed to compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in patients with known or suspected Gram-positive abSSSI (acute bacterial skin and skin structure infections) at 48 -72 hours after initiation of treatment. This study was conducted pursuant to a special protocol agreement (SPA) with the FDA based on the FDA\'s Guidance for Developing Drugs for Treatment of ABSSSI.(NCT02127970)
Latest
news: * On April 24, 2015, Actavis 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). 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). The treatment-emergent adverse event rate for single dose dalbavancin was 22.3% compared to 21.1% for the two-dose regimen. The most commonly reported adverse events with an incidence >1% for the single dose of dalbavancin were nausea, headache, vomiting, diarrhea, and dizziness, similar in frequency to the two-dose regimen. Discontinuations due to treatment emergent adverse events were 1.7% and 1.4% for the single and two-dose regimens, respectively. Actavis plans to file a supplemental New Drug Application (sNDA) with these data in Q3 2015.
