(RxWiki News) Newborns who arrive early often face respiratory problems since their lungs may not yet be fully developed. A new drug approved by the FDA joins four others to treat these problems.
The drug Surfaxin (lucinactant) was approved by the FDA to prevent respiratory distress syndrome, a condition that occurs when premature newborns cannot make enough of the liquid that coats the inside of their lungs to keep them open.
"Talk to your doctor about your risks of delivering your baby early."
The absence of the liquid, called surfactant, can lead the lungs to collapse and make it difficult for the infant to breathe. The breathing problem symptoms usually appear immediately or within the first several hours after birth for preterm babies with the condition.
Surfaxin replaces the surfactant, coating the lungs to prevent collapse. It is the first FDA-approved drug for respiratory distress syndrome that was synthetically made instead of being made from animal products.
The approval follows a review of the results of a single randomized, controlled trial of the drug with 1,295 premature babies.
In the first half hour after they were born, the early newborns received either Surfaxin or one of two other drugs already used to treat the respiratory problems - Exosurf (colfosceril palmitate) or Survanta (beractant).
The researchers were primarily comparing Surfaxin to Exosurf in terms of its effectiveness, but Survanta was included as a secondary comparison drug for the trial.
The babies who received Surfaxin showed a "significant improvement," according to the FDA, in their respiratory distress symptoms in their first 24 hours of life outside the womb when compared to the babies who took Exosurf.
The babies who took Surfaxin also had better mortality rates - they were more likely to live - than the babies who took Exosurf over their first two weeks after birth.
The most common side effects shown from use of Surfaxin included problems associated with the need to give it to babies through a breathing tube. The effects included endotracheal tube reflux and endotracheal tube obstruction as well as pale skin and the need to interrupt the dose because of breathing tube difficulties.
No information was available regarding the potential cost of Surfaxin.
Besides Surfaxin and the other two in the trial, Survanta and Exosurf (which is no longer marketed), two other FDA-approved drugs are available to treat respiratory distress syndrome: Curosurf (poractant alpha) and Infasurf (calfactant).
Surfaxin is manufactured by Discovery Laboratories Inc. in Warrington, Pa. The news was announced by the FDA in a press release distributed March 6.