New molecular entity: FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS.
On March 6, 2012, FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Lucinactant joins 4 other drugs marketed in the United States for the same indication, including beractant (Survanta, Abbott), poractant alpha (Curosurf, Chiesi), and calfactant (Infasurf, Ony). Lucinactant should not be administered to adults suffering from acute respiratory distress syndrome (ARDS) because of an increased risk of death, multiorgan failure, sepsis, anoxic encephalopathy, renal failure, hypoxia, pneumothorax, hypotension, and pulmonary embolism.
Efficacy. While lucinactant efficacy was evaluated in 2 randomized controlled trials, the trial dubbed SELECT (Safety and Effectiveness of Lucinactant vs. Exosurf in a Clinical Trial), was the pivotal phase 3 RDS prevention study that gained the drug US marketing approval. The SELECT trial was a randomized trial of 1,294 premature infants (600 g to 1,250 g at birth) which compared lucinactant at a dose of 5.8 mL/kg given up to 4 times (N=524) to colfosceril palmitate (Exosurf, which is no longer marketed in the United States) (N=506) or beractant (N=258) administered at FDA recommended doses. Compared with colfosceril palmitate, lucinactant demonstrated significant improvement in the proportion of premature infants suffering from RDS (defined as having a chest X-ray consistent with RDS and a FiO2 ≥0.30) at 24 hours after birth (39% vs 47%, P<.01) and lower RDS-related mortality through 2 weeks (5% vs 9%, P<.01).
Safety. In SELECT, the most common adverse effects of lucinactant are related to its administration down a premature infant's endotracheal tube and include endotracheal tube reflux (18 events per 100 doses), skin paleness (9 events per 100 doses), and endotracheal tube obstruction (6 events per 100 doses), often resulting in infants needing a dose interruption (9 events per 100 doses). Administration-related adverse reactions were more common in premature infants receiving lucinactant compared to control surfactants. Oxygen desaturation was reported in 17%, 9%, and 13% and bradycardia for 5%, 2%, and 3% of infants treated with lucinactant, colfosceril palmitate, and beractant, respectively.