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FDA Approves Shorter, More Aggressive Levaquin Therapy for Treatment of Acute Bacterial Sinusitis

The U.S. Food and Drug Administration (FDA) has recently approved a new Levaquin (levofloxacin) treatment method to treat acute bacterial sinusitis. The new Levaquin tablet treatment is a five day, 750 mg once-daily regimen. The regimen comes in a Leva-pak and is the first and only short course fluoroquinolone regimen that has been approved for treating acute bacterial sinusitis. The FDA approved the drug based on a clinical study that found this shorter treatment regimen to be as effective as a traditional regimen of Levaquin that is 500 mg for 10 days, double the amount of time as the new treatment.

Sinusitis is, according to the National Ambulatory Medical Care Survey, the fifth most common condition for which antibiotic is prescribed, and one of the most common conditions seen by primary care physicians. There are about 20 million cases of acute bacterial sinusitis every year in the United States alone. Levaquin is prescribed for some adults with acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis, the most common causes of acute bacterial sinusitis

"This new dosing regimen for sinusitis falls in line with the American Academy of Family Physicians and World Health Organization antibiotic recommendations which call for more aggressive, shorter courses of therapy that could also help reduce bacterial resistance," said Michael D. Poole, M.D., Ph.D., Georgia Ear and Sinus Institute, Savannah, Georgia. "Physicians now have another effective dosing option that provides patients with favorable symptom improvement and increased dosing convenience."

The approval is based on a multi-center, randomized, double-blind clinical study that assessed 780 adult outpatients diagnosed with acute bacterial sinusitis. The main outcome measured in this study was the complete or partial resolution of the signs and symptoms of acute bacterial sinusitis to the degree that no further antibiotic treatment was necessary.

Clinical success rates of 91.4 percent were seen in the 750 mg/five-day group and 88.6 percent for the 500 mg/10-day group. This means that the high-dose, short-course regimen delivered equivalent efficacy in half the treatment time. More importantly, these high rates of clinical success were maintained at one month and no new or unexpected adverse events were seen in either treatment group.


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