Single Dose of Azithromycin Microspheres as Effective as Multi-Dose for Respiratory Tract Infections in Adults

Main Category: Respiratory / Asthma
Article Date: 02 Nov 2004 - 12:00 PDT

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Three head-to-head studies presented during the 44th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington show that Pfizer Inc.'s new investigational microsphere formulation of azithromycin, which is dosed as a one-time-only oral antibiotic, is comparable to other frequently prescribed treatments for some of the most common respiratory tract infections in adult patients. Azithromycin has been available in the United States since 1992 under the tradename Zithromax®. Pfizer sponsored the studies and has submitted the data for review by the U.S. Food and Drug Administration. The Company is seeking approval for the treatment of adult respiratory tract infections, including acute bacterial exacerbations of chronic bronchitis (AECB) acute bacterial sinusitis (ABS) and community acquired pneumonia (CAP).

These three studies showed that with one dose, azithromycin microspheres provides a complete course of therapy for the treatment of AECB, ABS and CAP. Azithromycin microspheres was compared to a seven-day regimen of clarithromycin XL for the treatment of CAP and to seven- and ten-day courses of levofloxacin for the treatment of AECB and ABS, respectively.

"Given the efficacy of a one-time-dose for these common infections and the assured compliance, the hope would be that this type of regimen can help minimize the emergence of antibiotic resistance," said Michael Niederman, M.D., chairman of the Department of Medicine at Winthrop-University Hospital, Mineola, N.Y. and professor of Medicine at the State University of New York at Stony Brook. "Antibiotic resistance is a growing problem in the treatment of community respiratory tract infections, and one of the factors that contributes to its development is patients taking an incomplete course of therapy."

Study Results

In two of three multicenter, randomized, double-blind, double-dummy trials presented, azithromycin microspheres was compared to levofloxacin. One study examined azithromycin microspheres (2.0 g) and levofloxacin (500 mg/day for seven days) in 446 subjects with AECB. The clinical cure rate in the azithromycin microspheres group was comparable (95 percent) to the levofloxacin group (96 percent). Chronic bronchitis is characterized by excessive cough and sputum production on most days for at least three months during at least two consecutive years with intermittent acute exacerbations. AECB are usually manifested as an increase in dyspnea (difficult or labored breathing), sputum volume and/or sputum purulence (pus).1

Azithromycin microspheres was also compared to levofloxacin (500 mg/day for ten days) in 541 patients with ABS. Clinical success rates were comparable-94.5 percent of patients treated with azithromycin microspheres and 92.8 percent of levofloxacin-treated patients. ABS is an acute infection of the sinuses that can cause purulent nasal discharge, nasal congestion, fever and facial pain or tenderness.2

In another study presented during the meeting, the new formulation of azithromycin was compared to clarithromycin XL (1 g/day for seven days) in 501 randomized subjects with mild-to-moderate CAP. Treatment with azithromycin microspheres resulted in comparable pathogen eradication rates (91.8 percent) vs. clarithromycin XL (90.5 percent). The clinical success rate in the azithromycin microspheres group was 92.6 percent vs. 94.7 percent in the clarithromycin XL group. CAP is a lung infection acquired outside of hospitals or extended-care facilities.3

"A one-dose-only treatment is a significant advance, giving physicians and patients an option that can effectively treat the most common respiratory tract infections that occur in adults, while also providing an additional benefit regarding noncompliance with therapy," said Joseph Feczko, M.D., president of Worldwide Development, Pfizer Inc.

Safety and Tolerability

The new formulation of azithromycin microspheres offers a safety profile comparable to other antibiotic treatments for common respiratory tract infections and is generally well tolerated. In clinical studies, side effects were generally mild and resolved within two days for the majority of patients. The most common adverse events on day one were diarrhea/loose stools (11.7 percent), nausea (3.9 percent), abdominal pain (2.7 percent) and vomiting (1.1 percent).4 Patients with known hypersensitivity to azithromycin, erythromycin or any macrolide or ketolide antibiotic should not take azithromycin microspheres.

About Azithromycin Microspheres

The new azithromycin formulation allows for delayed release of drug, which occurs in the small intestine instead of in the stomach, maintaining tolerability. This, together with the long half-life of azithromycin microspheres, makes it possible to deliver the entire two-gram dose as a single dose regimen.

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

1 Niederman, Michael S. "Nationalise: North American Taskforce on Improving Outcomes in AECB and LRTIs - Implementation, Strategies and Education." Supplement to Consultant. Oct 2002, Vol 42, Num 12, pgs. S3-S4.

2 Piccirillo JF. "Acute Bacterial Sinusitis." New England Journal of Medicine. 2004; 351:902-910. Number 9

3 Schmitt SK. "Community-Acquired Pneumonia." The Cleveland Clinic Foundation. 2004.

4 Pfizer product insert: Azithromycin microspheres.

DISCLOSURE NOTICE: The information contained in this document is as of November 1, 2004. Pfizer assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments.

This document contains forward-looking information about a product formulation that is under review by the Food and Drug Administration ("FDA").There is no assurance as to when, or if, we will receive regulatory approval for the use of this formulation as discussed in this document. A further list and description of risks, uncertainties and other matters relating to the Company's future operating and financial performance can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and in its periodic reports on Forms 10-Q and 8-K.