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.