NEW YORK, June 14-The FDA has approved Zmax (azithromycin extended release) as a single-dose treatment for adults with pneumonia and certain types of acute bacterial sinusitis and pneumonia, Pfizer announced yesterday.
Having a once-only liquid antibiotic treatment could help improve compliance among older patients, said Pfizer. A single two-gram dose proved more potent than a standard dose of immediate-release Zithromax, with three times more Zmax found in tissue during the first 24 hours, said the New York drug firm.
"Results showed that one dose of Zmax was as effective as currently available treatments that must be taken for seven to 10 days," said Joseph Feczko, M.D., a vice president and chief medical officer for Pfizer.
Zmax is released into the small intestine instead of the stomach, said Pfizer, providing a surge in drug levels during the onset of a bacterial infection when the bacterial count is highest.
The drug is designed to treat acute bacterial sinusitis caused by Haemophilu influenzae, Morxella catarrhalis, or Streptococcus pneumoniae, and also community-acquired pneumonia caused by Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae.
Clinical trials showed diarrhea and loose stools to be the most common complaint associated with Zmax, followed by nausea and abdominal pain. Pfizer said diarrhea cleared up within two days among the Zmax-treated patients.
Pfizer originally had also sought approval of Zmax for acute bacterial exacerbations of chronic bronchitis, but withdrew that application.
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