FDA approves respiratory distress drug for infants
Drug Approved to Prevent Respiratory Distress Syndrome
HealthDay News -- The FDA has approved Surfaxin (lucinactant) to prevent respiratory distress syndrome (RDS) in premature infants.
Premature infants born before 37 weeks' gestation often cannot produce surfactant, a liquid that coats the lungs and prevents them from collapsing, the FDA said in a press release. Most babies with RDS show signs of breathing problems within the first hours after birth.
The agency approved Surfaxin after the drug's safety and efficacy was demonstrated in a single randomized, active-controlled, multi-dose study involving 1,294 premature infants. Those who received Surfaxin experienced significant improvement in both RDS at 24 hours after birth and RDS-related mortality through two weeks compared with Exosurf (colfosceril palmitate), another RDS drug that is no longer marketed.
Most side effects involved the breathing tube used to administer the drug. Adverse reactions included tube reflux or obstruction, skin paleness and the need for dose interruption.
Surfaxin is the fifth FDA-approved drug for respiratory distress syndrome. The other FDA-approved surfactants include Survanta (beractant), Curosurf (poractant alpha), Infasurf (calfactant) and Exosurf (colfosceril palmitate).
Surfaxin is produced by Discovery Laboratories, Inc., of Warrington, Penn.