The US FDA has approved the once-daily antibiotic Avelox (moxifloxacin HCl) of Schering-Plough Corporation for the treatment of complicated skin and skin structure infections (cSSSI) in adults caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae. Avelox was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering- Plough.

There are 2.5 million cSSSI cases in the US annually, with approximately 400,000 patients requiring hospitalization. Treatment of these infections typically involves high doses of antibiotics, often requiring multiple doses per day.

"This new indication for Avelox represents a meaningful alternative treatment approach for patients and an important new offering for Schering- Plough's anti-infectives portfolio," said Robert J. Spiegel, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.

Schering-Plough acquired exclusive US rights to market, sell and distribute Bayer's fluoroquinolone antibiotics Avelox and Cipro (ciprofloxacin) in October 2004. As holder of the New Drug Application (NDA) and patents for Avelox, Bayer completed the research and FDA submission related to this new indication, says the company release.

In the studies on which the FDA approval was based, sequential intravenous or oral monotherapy with Avelox once daily for cSSSI patients demonstrated similar efficacy to IV piperacillin-tazobactam four times daily followed by oral amoxicillin-clavulanate twice daily.

The FDA approval to treat cSSSI is the fifth indication for Avelox, which is currently approved in the United States to treat acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), community acquired pneumonia (CAP) and uncomplicated skin and skin structure infections (uSSSI).