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 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 made from cow or pig lung extract.
This is the first publication of these data, which have been presented previously in part at medical conferences. The study was funded in part by a grant from Discovery Laboratories, Inc. Dr. Marla Wolfson does not have a financial interest in Discovery Laboratories, Inc.
SURFAXIN (lucinactant intratracheal suspension) is the first surfactant approved by the United States Food and Drug Administration in the 21 st century and the only approved synthetic, peptide-containing surfactant. SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. Discovery Labs anticipates that SURFAXIN will be commercially available in late 2012.IMPORTANT SAFETY INFORMATION SURFAXIN (lucinactant intratracheal suspension) is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status. Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized. SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).