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US FDA nod for new levofloxacin regimen to treat acute bacterial sinusitis



11 August, 2005: Johnson& Johnson has received the US FDA approval for a levofloxacin regimen to treat acute bacterial sinusitis.

This new five-day, 750 mg once-daily is the first and only short course fluoroquinolone regimen approved for the treatment of acute bacterial sinusitis, the company said in a press release.

The approval is based on a clinical study that found this shorter treatment regimen as effective as a traditional regimen of Levaquin (levofloxacin) 500 mg for 10 days.

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, the release stated.

The approval is based on a multi-centre, 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. The drug 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 percent (n=139/152) were seen in the 750 mg/five-day group and 88.6 percent (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 the drug were both 100 percent. 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 percent) and H. influenzae (99.7 percent), as well as M. catarrhalis (100 percent) 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.

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

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.

Ortho-McNeil, Inc., along with Johnson & Johnson Pharmaceutical Research and Development, L.L.C., conducted the research supporting the approval of the drug. Ortho-McNeil, Inc., located in Raritan, NJ, markets prescription medicines in the areas of infectious disease, pain treatment and gastrointestinal disorders, the release added.


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