Pfizer Inc announced 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, 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.