FDA Approves AVELOX Antibiotic for Abdominal Infections

Despite the need for new antibiotics, there is ongoing incremental progress such as this approval. AVELOX (moxifloxacin HCl) is an existing once-daily, broad-spectrum antibiotic that has just been approved for the treatment of complicated, intra-abdominal infections (cIAI) in adults. According to a press release, "AVELOX is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication."

Here's some more:

Intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that cause bacteria to leak from the gastrointestinal tract into adjacent tissue. There are approximately 3.5 million cases in the United States each year, with many patients contracting the infection secondary to appendicitis.

"The FDA approval of AVELOX to treat complicated intra-abdominal infections is welcome news, providing doctors with an effective treatment option for their patients, and giving patients convenient once-daily dosing and an easy transition from I.V. to oral therapy when they leave the hospital," said Joseph S. Solomkin, M.D., professor in the department of surgery and director of research of the division of trauma/critical care at the University of Cincinnati College of Medicine.

With this FDA approval, AVELOX is indicated for the treatment of adults with cIAI, including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.

The FDA approval was based on results from clinical studies in cIAI patients showing that sequential I.V. or oral monotherapy with AVELOX once daily was as effective as the widely used I.V. therapy piperacillin-tazobactam four times daily followed by oral amoxicillin-clavulanate twice daily. AVELOX was effective at eradicating key pathogens, including E. coli and the anaerobe B. fragilis, which are the most commonly encountered bacteria in cIAI.