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.Advanced Life Sciences has reported positive results from a double-blind, randomized, parallel trial CL07-001, a thorough QT study of the company's novel once-a-day oral antibiotic, cethromycin.
Subscribe to our email newsletter
The trial has evaluated the potential of cethromycin to cause a prolongation in electrocardiographic QT interval. At the therapeutic and supratherapeutic doses, cethromycin showed no signal of any electrocardiographic effects and, hence, the study supported its favorable cardiac safety profile.
This study was conducted to evaluate the cardiac safety of cethromycin and to enhance the safety database for the company’s upcoming new drug application (NDA) submission for cethromycin to treat community acquired pneumonia. The FDA requires thorough QT studies for all new chemical entities because prolongation in QT interval (corrected for changes in heart rate, or QTc) may signify an increased risk of developing cardiac arrhythmias.