Surfaxin Approved to Prevent Respiratory Distress Syndrome
WEDNESDAY, March 7 -- Surfaxin (lucinacant) has been approved by the U.S. Food and Drug Administration to prevent respiratory distress syndrome, a serious lung condition that affects infants born prematurely.
Premature birth is defined as being born before 37 weeks' gestation. The lungs of infants born this early can't produce surfactant, a liquid that coats the lungs and prevents them from collapsing. Most babies with respiratory distress syndrome show signs of breathing problems within the first hours after birth, the FDA said in a news release.
Surfaxin, the fifth FDA-approved drug for respiratory distress syndrome, was evaluated in clinical studies involving nearly 1,300 premature infants. 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 produced by Discovery Laboratories, of Warrington, Penn.
The U.S. National Library of Medicine has more about respiratory distress syndrome.
Posted: March 2012