Orphan status for Surfaxin for BPD

Discovery Laboratories say that the Office of Orphan Products Development of the US Food and Drug Administration has granted Orphan Drug designation to the firm's lead product Surfaxin (lucinactant), for the prevention of bronchopulmonary dysplasia (BPD, also known as chronic lung disease) in premature infants. Surfaxin, a precision-engineered lung surfactant replacement therapy, has previously received OD stataus for the treatment of BPD, as well as fast-track designation for both the prevention and treatment of BPD.

The company explains that 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 it, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in respiratory distress syndrome. To prevent and treat RDS, babies require a surfactant usually within the first hours of birth, and mechanical ventilation to support their respiration. The lack of surfactant and use of mechanical ventilation may cause chronic injury and scarring of the lungs -resulting in BPD, says Discovery.