Breathing problems are not uncommon among preterm babies who may be exposed to respiratory-support as soon as they are born. Professionals at the US Food and Drug Administration (FDA) have approved of the drug namely Surfaxin for the treatment of respiratory distress syndrome (RDS) in premature infants.
This disorder usually takes place due to lack of sufficient surfactant in the lungs of the aforesaid infants. Surfaxin is cited to be the fifth drug gaining approval for the treatment of this condition in premature babies. To issue the consent, the team conducted an extensive trial comprising nearly 1,294 preterm infants.
In the trial, the babies were exposed to Surfaxin after 30 minutes of delivery. 2 other drugs namely Exosurf and Survanta served as comparisons. As per the outcomes, the subjects seemed to experience substantial improvement in their symptoms a day after birth as well as 2 weeks later, relative to Exosurf. This study was a multi-dose, randomized and active-controlled trial that was conducted to gauge the efficacy and safety of the drug.
The commonly reported side-effects of the aforesaid medicine included endotracheal tube obstruction, endotracheal tube reflux, dose interruption requirement, skin paleness and endotracheal tube obstruction. With this assent, the medication joins the league of other FDA-approved surfactants such as Exosurf (colfosceril palmitate), Curosurf (poractant alpha), Survanta (beractant), and Infasurf (calfactant). Exosurf is not being marketed at present.
Discovery Laboratories have manufactured Surfaxin.