Pharmaceutical Business review

Schering-Plough’s Avelox shows efficacy in trial

Avelox is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat cIAI, and has been shown to be effective at eradicating the most common bacteria that cause cIAI, including E. coli and B. fragilis.

“Complicated intra-abdominal infections often involve several different kinds of bacteria and require broad-spectrum antibiotic therapy for effective treatment,” said Robert Spiegel, senior vice president at Schering-Plough Research Institute.

The study compared the efficacy and safety of moxifloxacin to that of combination therapy in the treatment of cIAI. In the study, moxifloxacin monotherapy was as effective as the combination regimen in treating patients with cIAI. Overall clinical cure rates were 80.9% in the group receiving moxifloxacin and 82.3% in the group receiving the combination therapy regimen.

In the study, 19% of the moxifloxacin patients and 12.5% of the patients in the comparator arm experienced at least one drug-related adverse event.

Approximately 3.5 million Americans are diagnosed annually with cIAIs, which are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue.