Aerogen, Inc. has received Fast Track Designation from the US FDA for the Combination Product: Amikacin Pulmonary Delivery System for Ventilator-Associated Pneumonia (VAP). The product is Aerogen's lead drug/device combination product incorporating Aerogen's OnQ Aerosol Generator technology adapted for high efficiency aerosol delivery to patients on mechanical ventilators.

According to the release, the FDA granted Combination Product: Amikacin Pulmonary Delivery System fast track designation for -VAP is a significant cause of morbidity and mortality in the intensive care unit (ICU), with an associated mortality rate of up to 50 per cent. Patients with VAP have significantly longer duration of mechanical ventilation, ICU stay and hospital stay.

While Gram-negative organisms associated with VAP can be treated with aminoglycosides intravenously, parenteral delivery results in poor penetration of drug into the respiratory secretions and can cause significant adverse systemic effects. Targeted delivery of amikacin directly to the lungs takes advantage of the concentration-dependent killing of aminoglycoside antibiotics and has the potential to hasten resolution of the infection. The combination of high antibiotic concentrations at the infection site with low serum levels offers the possibility of reducing systemic toxicity, the release says.

"We are excited about the potential to significantly improve the treatment of patients with VAP using Aerogen's aerosolized amikacin product and are delighted with FDA's decision to grant Fast Track Designation for our programme," said Dr. Robert Fishman, VP of Scientific Affairs.