A new surfactant, lucinactant, has been approved for prevention of respiratory distress syndrome in premature infants, the fifth surfactant approved in the United States, the Food and Drug Administration announced on March 6.
The safety and efficacy of lucinactant was demonstrated in a randomized active controlled multidose study of 1,294 premature infants, comparing it with two of the other approved surfactants, according to the FDA statement announcing the approval.
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The safety and efficacy of lucinactant was demonstrated in a randomized active controlled multidose study of 1,294 premature infants, comparing it with two of the other FDA-approved surfactants.
In the study, the infants were treated with lucinactant (Surfaxin), colfosceril palmitate (Exosurf), or beractant (Survanta) within 30 minutes of birth. Those treated with lucinactant had significant improvement in respiratory distress syndrome at 24 hours after birth and RDS-related mortality through 2 weeks, when compared with those treated with colfosceril, the statement said. Colfosceril, which is no longer marketed in the United States, was used as the primary comparator in the study, according to the statement.
The most common side effects associated with the lucinactant were associated with intratracheal administration, and included endotracheal tube reflux, endotracheal tube obstruction, and need for dose interruption, the statement said.
In addition to colfosceril and beractant, the other two FDA-approved surfactants are poractant alpha (Curosurf) and calfactant (Infasurf).
Lucinactant, which is a suspension formulation intended for intratracheal use only, will be marketed as Surfaxin by Discovery Laboratories Inc. A statement issued by the company said that it anticipates that the product will be available in the United States in late 2012. The company describes it as a synthetic, peptide-containing surfactant.