Company reveals outcome of Topline Phase 3 Clinical Trial for Single-Dose DALVANCE’ (dalbavancin) in the Treatment of ABSSSI.
Actavis plc has 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.
About the DUR001-303 Trial
This study was conducted pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA’s Guidance for Developing Drugs for Treatment of ABSSSI. DUR001-303 was a randomized, double-blind, double-dummy trial conducted in 698 patients at 62 sites in the United States, Europe and South Africa comparing a single 1500 mg intravenous (IV) dose of DALVANCE to the approved regimen of two-doses given one week apart (1000 mg IV on Day 1 followed by 500 mg IV on Day 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.
DALVANCE’ (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).
DALVANCE is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.
Actavis plc, headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model ‘ Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Actavis markets a portfolio of best-in-class products that provide valuable treatments for the women’s health, central nervous system, eye care, medical aesthetics, gastroenterology, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of
generic product applications globally.
With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Actavis intends to adopt a new global name ‘ Allergan ‘ pending shareholder approval in 2015.
For more information, visit Actavis’ website at www.actavis.com.