Lucinactant (trade name Surfaxin) is a liquid medication used to treat
infant respiratory distress syndrome.[1] It is a
pulmonary surfactant for infants who lack enough natural surfactant in their lungs. Whereas earlier medicines of the class, such as
beractant (Survanta & Beraksurf),
calfactant (Infasurf), and poractant (Curosurf), are derived from animals, lucinactant is
synthetic. It was approved for use in the United States by the U.S. Food and Drug Administration (FDA) on March 6, 2012.[2]
The scientific groundwork for lucinactant was laid in the laboratory of Charles Cochrane at The
Scripps Research Institute in the 1990s.[7] The drug was then developed by Discovery Laboratories of
Warrington, PA. The path through the approval process was unusually long, reflecting in part challenges in the manufacturing process that needed to be addressed before approval was granted.[8]
Legal status
Lucinactant is listed as an
Orphan Drug Product by the US Food and Drug Administration for several conditions:[9][10]
07-30-1996 Treatment of meconium aspiration syndrome in newborn infants
07-17-1995 Treatment of acute respiratory distress syndrome in adults.
05-23-2006 Prevention of bronchopulmonary dysplasia in premature infants
10-21-2005 Treatment of bronchopulmonary dysplasia in premature infants.
10-18-1995 Treatment of respiratory distress syndrome in premature infants.
Clinical trials in Latin America were criticized for protocol based in potentially unethical principles.[11] A placebo was used and considered ethical by design since infants born in Latin America usually do not have access to life saving treatment. The intent of Discovery Labs was always to market Surfaxin in the United States, implying burdens on the Latin American children that outweighed the benefits.[citation needed]
^Wiswell TE, Smith RM, Katz LB, Mastroianni L, Wong DY, Willms D, et al. (October 1999). "Bronchopulmonary segmental lavage with Surfaxin (KL(4)-surfactant) for acute respiratory distress syndrome". American Journal of Respiratory and Critical Care Medicine. 160 (4): 1188–95.
doi:
10.1164/ajrccm.160.4.9808118.
PMID10508806.
^
abDonn SM (March 2005). "Lucinactant: a novel synthetic surfactant for the treatment of respiratory distress syndrome". Expert Opinion on Investigational Drugs. 14 (3): 329–34.
doi:
10.1517/13543784.14.3.329.
PMID15833063.
S2CID6843316.
^Wiswell TE, Knight GR, Finer NN, Donn SM, Desai H, Walsh WF, et al. (June 2002). "A multicenter, randomized, controlled trial comparing Surfaxin (Lucinactant) lavage with standard care for treatment of meconium aspiration syndrome". Pediatrics. 109 (6): 1081–7.
doi:
10.1542/peds.109.6.1081.
PMID12042546.