Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Ireland based pharmaceutical firm Actavis has announced the top-line results for DUR001-303 which is a phase 3 study comparing a single 1500 mg dose of Dalvance with the same total dose given as two-doses one week apart.
Subscribe to our email newsletter
Dalvance is used for treating acute bacterial skin and skin structure infections (ABSSSI) which are caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).
DUR001-303 was a randomized, double-blind, double-dummy trial conducted in 698 patients at 62 sites in the US, Europe and South Africa comparing a single 1500mg intravenous (IV) dose of Dalvance to the approved regimen of two-doses given one week apart (1000mg IV on day 1 followed by 500mg IV on day 8).
According to the study, 1500mg single-dose of the drug reached its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48-72 hours after initiation of therapy, which was ascertained by a > 20% reduction in lesion area relative to the baseline measurement.
Actavis Global Brands R&D executive vice-president David Nicholson said: "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."
The trial also led to the secondary outcome of clinical response of the drug at Day 14 and Day 28. A single dose gave out similar efficient treatment results as the two dose regimen in these secondary endpoints.
The firm intends to file a supplemental New Drug Application (sNDA) with the research data in the third quarter this year.