The US Food and Drug Administration (FDA) has granted fast track designation to Discovery Laboratories' lead product, Surfaxin, for the prevention and treatment of bronchopulmonary dysplasia (BPD), also known as chronic lung disease in premature infants.

Robert J. Capetola, president and chief executive officer, Discovery Labs, said, "The FDA's decision to grant fast track designation to Surfaxin for BPD is important for the neonatal medical community. Presently there are no approved drugs for the treatment of BPD. Babies suffering from abnormal lung development have a need for respiratory assistance spanning from many months to years. It is estimated that the cost of treating an infant with BPD in the United States can approach USD 2, 50,000."

Surfaxin has already received an approvable letter from the FDA for the prevention of RDS in premature infants and anticipates potential approval in April 2006. To further develop Surfaxin for neonatal respiratory diseases, Discovery is currently conducting a phase 2 clinical trial to determine the safety and tolerability of administering Surfaxin as a therapeutic approach for the prevention and treatment of BPD, claims the company release.

The BPD study design provides that premature infants receive a treatment regime of up to five Surfaxin doses beginning within the first 3-10 days of life that are in addition to the surfactant they received on day 1 of life for RDS. The purpose of this study is to determine whether such treatment can decrease the proportion of infants on mechanical ventilation or oxygen supplementation or decrease the incidence of death or BPD. Results from this trial are expected in 2006.

Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and to maintain proper airflow through the respiratory system. Surfactant treatment options available today are limited to FDA approved animal-derived or non-protein containing synthetic products and are only approved for RDS. Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant.

In clinical trials comparing Surfaxin to the currently available products, Surfaxin demonstrated a significant survival advantage for RDS babies. If approved by the FDA, Surfaxin represents a potential alternative to the current surfactant treatment options for RDS.

BPD is a costly syndrome affecting premature infants. It is associated with surfactant deficiency and the prolonged use of mechanical ventilation and oxygen supplementation. Some premature babies are born with a lack of natural surfactant in their lungs. Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in Respiratory Distress Syndrome (RDS). To treat RDS, babies require a surfactant usually within one hour of birth as well as mechanical ventilation to support the babies' respiration. The lack of surfactant and use of mechanical ventilation may cause chronic injury and scarring of the lungs resulting in BPD.