Pfizer's extended-release azithromycin product Zmax has been approved for one-dose-only antibiotic therapy, the company said June 13.

FDA approved Zmax oral suspension as "a one-dose-only treatment for mild-to-moderate acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) in adults," Pfizer said.

The company described the product as using "microsphere technology" that allows the two-gram dose of drug to be absorbed in the small intestine rather than the stomach.

As a result, "the amount of drug that gets into the tissue is three times higher than a standard dose of immediate-release azithromycin," Pfizer said.

Pfizer markets immediate-release azithromycin as Zithromax .

Zmax is indicated for ABS due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae and CAP due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy, Pfizer said.

Pfizer also studied Zmax for use in acute bacterial exacerbations of chronic bronchitis (AECB). However, "Pfizer withdrew its application for the treatment of AECB while the FDA re-evaluates how it reviews investigational antibiotics for this indication," the company said.

- Scott Steinke

Pfizer Zmax Approved For One-Dose-Only Antibiotic Therapy

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