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LEDERLE'S SUPRAX(R) APPROVED TO TREAT GONORRHEA WITH ONE SINGLE ORAL DOSE; STUDIES SHOW TABLET TO BE MAJOR COST SAVINGS OVER INJECTION

    WAYNE, N.J., Feb. 22 /PRNewswire/ -- Lederle Laboratories, a division of American Cyanamid (NYSE: ACY), announced that its broad- spectrum antibiotic SUPRAX cefixime has now been approved for the treatment of uncomplicated gonorrhea using only one convenient oral 400mg. dose.
    SUPRAX, a cephalosporin marketed by Lederle since 1989 to treat acute otitis media and acute bronchitis, was shown in multi-center studies to be safe and effective treatment for gonorrhea, including cases caused by strains resistant to penicillin and certain other antibiotics.
    SUPRAX was shown to be as effective in treating gonorrhea as the injectable antibiotic ceftriaxone, currently recommended by the Centers for Disease Control for gonorrhea therapy.  Physicians taking part in the studies also found the SUPRAX 400mg. tablet easier and more convenient to administer to gonorrhea patients than the standard 250mg. injection of ceftriaxone.
    H. Hunter Handsfield, M.D., director of the S.T.D. Control Program of the Seattle-King County Department of Public Health and professor of medicine at the University of Washington, has acknowledged that "Single- dose cefixime is an excellent choice for initial treatment of uncomplicated gonorrhea."
    A team led by Dr. Handsfield conducted a study involving 68 men and 55 women at the Seattle-King County S.T.D. Clinic which found that a single 400mg. dose of SUPRAX was 96 percent effective in curing uncomplicated gonorrhea.
    A second separate study conducted by the New Orleans Department of Health and Tulane University School of Medicine found that use of SUPRAX rather than ceftriaxone to treat gonorrhea would result in major cost savings at public health clinics while maintaining quality of treatment (i.e., a 98 percent cure rate for SUPRAX).  The Tulane/New Orleans study determined that use of SUPRAX instead of ceftriaxone would yield significant yearly savings of more than $37,500 at the city's single communicable disease health clinic alone.
    "Because of its effectiveness against certain resistant strains of bacteria and its convenient, one-time oral dosing, we have chosen SUPRAX as the treatment of choice for acute gonococcal urethritis in every state- and city-operated venereal disease clinic in Louisiana," said Brobson Lutz, M.D., director of health for the city of New Orleans and co-author of the Tulane study.
    "Patient acceptance of SUPRAX is high because it eliminates the need for injections.  And, it eliminates the risk of health care workers accidentally infecting themselves through needlesticks with HIV, hepatitis B and other bloodborne infections," Dr. Lutz added.  "SUPRAX also saves costs associated with syringe acquisition, syringe and needle disposal, and nursing staff time in giving injections."
    U.S. studies of SUPRAX in the treatment of gonorrhea were also conducted at the Baltimore Health Department and Johns Hopkins University School of Medicine in Baltimore; State University of New York (S.U.N.Y.) Health Science Center in Brooklyn; and the Denver Department of Health and University of Colorado.  The supplemental New Drug Application (NDA) for the gonorrhea indication was filed by Lederle on April 12, 1991; it was approved on Feb. 5, 1993.
    According to the U.S. Centers for Disease Control, there were 620,478 cases of gonorrhea reported in the U.S. in 1991.  Not all cases are reported, however, and the total is estimated at 1 - 1.5 million cases annually.  Up to 20 percent of cases are due to gonorrhea strains that are resistant to penicillin, but not to SUPRAX or ceftriaxone.
    The new indication states that SUPRAX is approved for the treatment of uncomplicated cervical/urethral gonorrhea due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase producing strains).
    The CDC and other health experts recommend that therapy be followed by seven days of treatment with doxycycline.  This additional antibiotic treats chlamydia, another sexually transmitted infection which is present in up to 20 percent of men and 40 percent of women with gonorrhea.
    SUPRAX is also indicated for the treatment of acute exacerbation of chronic bronchitis, pharyngitis, tonsillitis and urinary tract infections.
    Lederle Laboratories is a research intensive organization that manufactures and markets a broad range of products including ethical pharmaceuticals, vaccines, generics, and vitamins and nutritionals worldwide.
    For additional information, please contact:
    H. Hunter Handsfield, M.D.            Brobson Lutz, M.D.
    Director of STD Control Program       Director of Health
    Seattle - King County                 City of New Orleans
     Department of Public Health          504-565-6912
    Professor of Medicine
    University of Washington
    206-223-5899
    -0-             02/22/93
    CONTACT:  Pat Fiaschetti of Lederle Laboratories, 201-831-4684
    (ACY) CO:  LEDERLE LABORATORIES; AMERICAN CYANAMID IN:  MTC ST:  NJ


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Date:Feb 22, 1993
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