Surfaxin Approved for Prevention of Respiratory Distress Syndrome

SURFAXIN (lucinactant) 8.5mL intratrachial suspension by Discovery Laboratories
SURFAXIN (lucinactant) 8.5mL intratrachial suspension by Discovery Laboratories

Discovery Laboratories announced that the FDA has approved Surfaxin (lucinactant intratracheal suspension) for prevention of respiratory distress syndrome (RDS) in high-risk premature infants. Surfaxin is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Currently, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive.  

The safety and efficacy of Surfaxin was demonstrated in a large, multinational phase 3 clinical study that included 1,294 patients. It is anticipated that Surfaxin will be commercially available in the United States in late 2012.

For more information visit www.surfaxin.com.