NEW YORK, Nov. 7 /PRNewswire/ -- Pfizer Inc said today that an Advisory
Committee to the U.S. Food and Drug Administration recommended approval of
Zithromax (azithromycin for oral suspension) as both a single-dose regimen and
a three-day regimen for the treatment of acute otitis media in pediatric
patients.
    Acute otitis media, which is an inflammation of the middle ear, is the
most common infection in young children.  It accounts for at least 30 million
sick child visits to doctors each year.
    Developed and marketed by Pfizer, Zithromax was approved in 1995 as the
first azalide antibiotic for use in children with acute otitis media caused by
Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis.
The current approved treatment regimen of Zithromax is once-daily for five
days, while most currently available antibiotics require 10 days of multi-dose
treatment.  Zithromax has unique attributes that include high and sustained
drug levels in infected tissues, which make short-course dosing possible.
    "Children may experience serious complications if ear infections are not
properly diagnosed and treated," said Joseph Feczko, M.D., Pfizer's Senior
Vice President of Medical and Regulatory Operations.  "Zithromax as a
single-dose regimen can increase the likelihood that patients complete the
full course of their treatment.  Of course, only a physician can decide if an
antibiotic is necessary."
    The one-dose Zithromax clinical program involved nearly 800 patients with
acute otitis media between the ages of 6 months and 12 years.  Of these, over
480 received a single-dose regimen of Zithromax.  In a pivotal comparative
trial, a single dose of Zithromax was as effective as Augmentin
(amoxicillin/clavulanate potassium) taken twice a day for 10 days.
Furthermore, compliance with one dose of Zithromax was significantly better
than with the multi-dose Augmentin regimen (99 percent vs. 83 percent,
respectively).
    Clinical trial patients receiving a single dose of Zithromax also
experienced fewer overall side effects than those receiving Augmentin.  In the
clinical program, the most common treatment-related side effects of the
single-dose regimen of Zithromax oral suspension were vomiting (4.9 percent),
diarrhea/loose stools (4.3 percent), abdominal pain (1.4 percent), and nausea
(1 percent). Zithromax should not be taken by patients with a hypersensitivity
to azithromycin, erythromycin or any macrolide antibiotic.
    Zithromax was first approved in the United States in 1992 in capsule form
for adults as the first once-daily, five-day oral antibiotic for the treatment
of community-acquired respiratory infections and skin infections.

    Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines for humans and animals, and many of the world's
best-known consumer products.

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