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Published on 4/7/2006 in the Prospect News Biotech Daily.

Schering-Plough says Avelox monotherapy as effective as high-dose combination therapy

By Elaine Rigoli

Tampa, Fla., April 7 - Avelox (moxifloxacin HCl) monotherapy at 400 mg once daily is as effective as the high-dose combination of levofloxacin (500 mg twice daily) plus ceftriaxone (2 g once daily) in treating patients with severe community-acquired pneumonia (CAP) requiring hospitalization, according to results of a Schering-Plough clinical study.

Known as the Motiv (moxifloxacin treatment intravenous) study, the head-to-head comparison of once-daily Avelox monotherapy to a combination of high-dose levofloxacin plus high-dose ceftriaxone showed no significant difference in clinical cure rates (four to 14 days after the last dose), the primary efficacy endpoint for the two per protocol treatment groups (86.9% vs. 89.9%, respectively).

This study also included CAP patients with the most severe pneumonia, according to a news release.

The per protocol population consisted of 569 patients. A total of 748 patients were enrolled in the study, of which 738 patients were randomized.

Both treatments were well tolerated in the study, with similar adverse event profiles.

CAP affects about 5.6 million adults in the United States each year, with elderly patients 60% more likely than the general population to develop the infection, the release said.

Avelox, a broad-spectrum fluoroquinolone antibiotic, has been shown to be safe and effective as monotherapy in treating patients with CAP and is approved for this indication.

Based in Kenilworth, N.J., Schering-Plough is a science-based health care company with prescription, consumer and animal health products.


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