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Aztreonam Lysine for Inhalation

Aztreonam lysine for inhalation is an antibiotic candidate currently being studied in Phase III clinical trials as a treatment for cystic fibrosis patients who have pulmonary Pseudomonas aeruginosa. Although the spectrum of activity for aztreonam is similar to that of tobramycin, its mechanism of action is different than that of aminoglycosides.1 Aztreonam (Azactam®) has been approved for IV administration in the U.S. since 1986. In both in vitro and clinical infections, aztreonam exhibits activity against a wide spectrum of gram-negative bacteria, such as Pseudomonas aeruginosa.2 The inhaled formulation is different than the IV form, as it does not include arginine. Arginine is a substrate for nitric oxide synthetase. Nitric oxide reacts with the superoxide anion to form peroxynitrite, which is pro-inflammatory.3 Instead, this formulation incorporates a lysine salt. Additionally, the pH and osmolality of aztreonam lysine are adjusted for inhalation. Based on results from two Phase III clinical studies, Gilead anticipates submitting a New Drug Application (NDA) for aztreonam lysine for inhalation to the U.S. Food and Drug Administration (FDA) by the end of 2007.

Aztreonam lysine for inhalation was developed for administration using the investigational PARI eFlow® Electronic Nebulizer. The eFlow® has been used in all clinical trials for aztreonam lysine for inhalation to date. Enrolled patients will receive both aztreonam lysine for inhalation and the eFlow® at no cost while participating in the program

  1. Brewer NS, Hellinger WC. The monobactams. Mayo Clin Proc. 1991;66(11):1152-7.
  2. Azactam® (aztreonam for injection, USP) Prescribing Information. San Diego, Calif; Elan Pharmaceuticals, Inc.; 2007.
  3. Mulligan MS, Hevel JM, Marletta MA, et al. Tissue injury caused by deposition of immune complexes is L-arginine dependent. Proc Natl Acad Sci USA. 1991;88 (14):6338-42.

Azactam is a registered trademark of Elan Pharmaceuticals, Inc.