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.