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Short Course Regimen of Fluoroquinolone Clears FDA Hurdle

RARITAN, N.J., Aug. 8 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new five-day, 750 mg once-daily regimen for LEVAQUIN(R) (levofloxacin) tablets to treat acute bacterial sinusitis. This regimen is available in the convenient Leva-pak and is the first and only short course fluoroquinolone regimen approved for the treatment of acute bacterial sinusitis. The approval is based on a clinical study that found this shorter treatment regimen as effective as a traditional regimen of LEVAQUIN 500 mg for 10 days.

Sinusitis is one of the most common conditions seen by primary care physicians, and according to the National Ambulatory Medical Care Survey, is the fifth most common condition for which an antibiotic is prescribed. Each year in the United States there are an estimated 20 million cases 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, MD, PhD, 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 evaluated 780 adult outpatients diagnosed with acute bacterial sinusitis. The primary 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. LEVAQUIN is indicated for adults with acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. These pathogens are the most common causes of acute bacterial sinusitis.

Clinical success rates of 91.4% (n=139/152) were seen in the 750 mg/five- day group and 88.6% (n=132/149) for the 500 mg/10-day group. This means that the high-dose, short-course regimen delivered comparable efficacy in half the treatment time. More importantly, these high rates of clinical success were maintained at one month. No new or unexpected adverse events were seen in either treatment group.

In this clinical trial, the in vitro susceptibilities of S. pneumoniae and H. influenzae to LEVAQUIN were both 100%. These susceptibility results are consistent with existing in vitro data from the Tracking Resistance in the United States Today (TRUST) study. TRUST has demonstrated sustained susceptibility to LEVAQUIN among S. pneumoniae (99%) and H. influenzae (99.7%), as well as M. catarrhalis (100%) isolates, since the study began nearly nine years ago. TRUST is the largest continuous, comprehensive respiratory pathogen surveillance study in the United States and is supported by Ortho-McNeil, Inc. In vitro susceptibility activity does not necessarily reflect clinical results.

This five-day, 750 mg once-daily dosing regimen of LEVAQUIN is also approved in adults for community-acquired pneumonia due to penicillin- susceptible Streptococcus pneumoniae (excluding multi-drug-resistant strains*), Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, or Mycoplasma pneumoniae. The overall tolerability of LEVAQUIN is similar across doses.

Important Safety Information
The most common drug related adverse events in U.S. clinical trials were nausea (1.5%) and diarrhea (1.2%).

The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx** (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least two hours before or two hours after levofloxacin administration.

* MDRSP (Multi-drug resistant Streptococcus pneumoniae) isolates are strains resistant to two or more of the following antibiotics: penicillin (MIC greater than or equal to 2 mcg/mL), 2nd generation cephalosporins, e.g. cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Source: Ortho-McNeil, Inc.

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