Lucinactant (Surfaxin™) for Prevention and Treatment of Respiratory Distress Syndrome in Newborns

Abstract

Respiratory distress syndrome, resulting from the deficiency of endogenous surfactant, remains a leading cause of mortality and morbidity in preterm infants. Exogenous surfactant replacement therapy is one of the most widely researched areas in neonatal medicine and is now accepted as the standard of care for preventing and treating respiratory distress syndrome in these newborns. Exogenous surfactant replacement therapy has evolved in the past three decades, but controversies still exist as to the choice of preparation (i.e., is one better than the others?), dosing and volume of individual preparations, and cost. At present, animal-derived surfactants that contain proteins appear to be the choice of most clinicians; however, they may have the limitation of being derived from animal sources. This has prompted the development of newer synthetic surfactants such as lucinactant (Surfaxin™, Discovery Laboratories, PA, USA), which contains the protein B mimic synthetic peptide, sinapultide. Although it is not yet commercially available or approved for clinical use by regulatory authorities, recent Phase III clinical trials with lucinactant demonstrated promising results with similar efficacy to animal-derived surfactants whilst avoiding the disadvantage associated with animal products. The availability of such a surfactant in large amounts at a relatively lower production cost should also prompt further investigations regarding expanded use of surfactants in conditions other than neonatal respiratory distress syndrome, such as meconium aspiration syndromes and pneumonia, and as a vehicle for administering drugs directly to the lungs. There are also some developments towards making aerosolized forms of surfactant, which could be administered noninvasively, thus obviating the need for endotracheal intubation and its associated complications. The purpose of this article is to provide an appraisal of the recent advances in surfactant replacement therapy and its future developments.