The multicenter, double-blind, randomized, controlled Phase IIIb trial compares a single dose of Dalvance with the once-weekly dosage regimen of Dalvance in adult patients with ABSSSI.
In the trial, a total of 410 adult patients will be randomized to receive either one 1500mg single dose of Dalvance on Day 1 or two doses of Dalvance with 1000mg on Day 1 followed by 500mg on Day 8.
ABSSSI is caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
The company said that all doses in the trial will be administered over 30 minutes through a peripheral IV.
For presumed Gram-negative pathogens, only IV aztreonam may be given at randomization and for suspected anaerobic pathogens, oral or IV metronidazole may be used.
Primary outcome measure for efficacy evaluation will be the percentage of patients in each treatment group who demonstrate a clinical response at 48-72 hours after the initiation of therapy with study medication.
The trial was designed to meet the new standards required by regulatory authorities for antibiotic development in the US.
Durata Therapeutics chief medical officer Michael Dunne said the company’s pharmacokinetic studies have indicated that there may be clinical efficacy in dosing Dalvance as a single 1500mg infusion over 30 minutes to treat ABSSSI.
"We are committed to advancing the care of patients with ABSSSI and potentially offering health care professionals an opportunity to choose the most appropriate dosing regimen based on patient and clinical needs," Dunne said.
In September 2013, the company has submitted a new drug application (NDA) seeking approval of Dalvance to treat ABSSSI with a once-weekly dosage regimen of 1000mg on Day 1 and 500mg on Day 8, each administered over 30 minutes.
The NDA was accepted for priority review by the FDA in November 2013 with an action date of 26 May 2014.