Patients
Download an overview of this EAP as a PDF.
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EAP Overview

The purpose of this expanded access program (EAP) is to make the experimental drug aztreonam lysine for inhalation available to people with cystic fibrosis (CF) who have Pseudomonas aeruginosa in their lungs and meet eligibility criteria. People with CF who have limited or no treatment options and are at risk for disease progression may enroll in this EAP through participating treatment centers in the United States.

As an experimental drug, aztreonam lysine for inhalation is not approved by the U.S. Food and Drug Administration (FDA). FDA rules allow drug manufacturers to "expand access" to their experimental products when there are people with limited or no treatment options who may benefit from the drug, but do not qualify for the clinical trials.

To be considered for an EAP by the FDA, the experimental drug must: (Chart)

Next: Learn about the experimental formulation of aztreonam lysine for inhalation

  1. U.S. National Institutes of Health. An Introduction to Clinical Trials. Available at: http://www.clinicaltrials.gov/ct/info/whatis#expanded. Accessed July 18, 2007.