Lucinactant approved to treat breathing distress

April 1, 2012

The US Food and Drug Administration has approved lucinactant, a new surfactant that prevents respiratory distress syndrome, most common in babies born 6 weeks or more before their due dates.

The US Food and Drug Administration (FDA) has approved lucinactant, a new surfactant that prevents respiratory distress syndrome (RDS), most common in babies born 6 weeks or more before their due dates.

A single multidose study proved lucinactant's safety and efficacy compared with other FDA-approved surfactants. In the study, 1,294 premature infants were given lucinactant, colfosceril palmitate, or beractant within 30 minutes of birth. The infants who received lucinactant demonstrated significant improvement in RDS at 24 hours and in RDS-related mortality through 2 weeks compared with infants who received the other surfactants.

The most common side effects of lucinactant are related to administration through the infant's endotracheal tube and include tube reflux or obstruction, pale skin, and dose interruption.