Discovery Laboratories, Inc., a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the United States Food and Drug Administration (FDA) has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012.
“The approval of SURFAXIN is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS,” said W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs. “This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care.” RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants.
