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| |  New Antibiotic Introduced Just In Time For Respiratory Season RESEARCH TRIANGLE PARK, NC -- November 7, 1997 -- The Food and Drug Administration (FDA) has cleared for marketing Raxar(TM) (grepafloxacin HCl) Tablets, a once-daily, broad-spectrum antibiotic for the treatment of patients with certain community-acquired infections, such as bronchitis, pneumonia and common sexually-transmitted diseases. Raxar will be available by prescription in local pharmacies by the second week in December. "Raxar, the newest fluoroquinolone, is an important addition to the choices physicians have for treating these infections because Raxar provides targeted coverage against the common respiratory bacteria and allows patients the convenience of once-a-day dosing," said George Sarosi, M.D., chief of medical service at Roudebush VA Medical Center in Indianapolis and professor of medicine at Indiana University School of Medicine. In vitro studies have shown grepafloxacin, the active ingredient in Raxar, penetrates the lung tissue, the site of lower respiratory tract infections, at high concentrations. Within forty minutes, the drug reaches concentrations in the lung tissue needed to eradicate the most prevalent respiratory bacteria. In recent years, bacterial resistance to commonly prescribed antibiotics has dramatically increased and represents one of the biggest concerns to physicians today. Raxar provides excellent activity against common respiratory bacteria, including those that have demonstrated resistance to traditionally-prescribed antibiotics such as amoxicillin. The results of an in vitro study showed Streptococcus pneumoniae -- one of the most prevalent respiratory bacteria -- is increasing. Resistance to penicillin reached nearly 36 percent and resistance to a more recent antibiotic, clarithromycin (Biaxin(R)) reached 23 percent. However, grepafloxacin provided activity against nearly 100 percent of strains of this bacteria that were resistant to penicillin and clarithromycin. "In this study, grepafloxacin demonstrated excellent coverage against Streptococcus pneumoniae, including strains resistant to penicillin. No other antibiotic tested in this study had greater activity against penicillin resistant Streptococcus pneumoniae than grepafloxacin," said Clyde Thornsberry, Ph.D., professor of pathology, Vanderbilt University in Nashville. The antibiotics tested in this study included amoxicillin, clarithromycin, azithromycin, ciprofloxacin and levofloxacin. Although in vitro data is a useful guide, clinical trial outcomes with grepafloxacin did not always correlate with in vitro study results. Raxar, the newest fluoroquinolone, is indicated for treatment of acute bacterial exacerbations of chronic bronchitis (ABECB) (caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis) and community-acquired pneumonia (CAP) (caused by S. pneumoniae, H. influenzae, M. catarrhalis, or Mycoplasma pneumoniae), which are the most common causative pathogens encountered by physicians in these infections. Raxar is also indicated for the treatment of uncomplicated gonorrhea caused by Neisseria gonorrhoeae and non-gonococcal cervicitis and urethritis caused by Chlamydia trachomatis. Raxar has a favorable safety profile. Most adverse events during clinical trials were transient, mild to moderate in severity and required no treatment. The most commonly reported side effects included nausea, vomiting, taste disturbance, headache, dizziness diarrhea, and vaginitis. Raxar is contraindicated in patients with known hypersensitivity to grepafloxacin or other fluoroquinolone antibiotics, in patients with hepatic failure, and in patients with known QTc prolongation or in those receiving QTc-prolonging drugs. Raxar is currently marketed in Germany under the trade name Vaxar(TM) and has been used in 20,000 patients worldwide. Raxar was licensed to Glaxo Wellcome by Otsuka Pharmaceutical Co., Ltd. of Japan.
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