Surfaxin
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Lucinactant (trade name Surfaxin) is a liquid medication used to treat
infant respiratory distress syndrome Infantile respiratory distress syndrome (IRDS), also called respiratory distress syndrome of newborn, or increasingly surfactant deficiency disorder (SDD), and previously called hyaline membrane disease (HMD), is a syndrome in premature infants c ...
. It is a
pulmonary surfactant Pulmonary surfactant is a surface-active complex of phospholipids and proteins formed by type II alveolar cells. The proteins and lipids that make up the surfactant have both hydrophilic and hydrophobic In chemistry, hydrophobicity is t ...
for infants who lack enough natural surfactant in their lungs. Whereas earlier medicines of the class, such as
beractant Beractant, also known by the trade name of Survanta, is a modified bovine pulmonary surfactant containing bovine lung extract (phospholipids, neutral lipids, fatty acids, and bovine surfactant proteins), to which synthetic DPPC, tripalmitin and p ...
(Survanta & Beraksurf), calfactant (Infasurf), and poractant (Curosurf), are derived from animals, lucinactant is
synthetic Synthetic things are composed of multiple parts, often with the implication that they are artificial. In particular, 'synthetic' may refer to: Science * Synthetic chemical or compound, produced by the process of chemical synthesis * Synthetic o ...
. It was approved for use in the United States by the U.S. Food and Drug Administration (FDA) on March 6, 2012.


Medical uses

Lucinactant is indicated to improve lung function and reduce duration and risk of
mechanical ventilation Mechanical ventilation, assisted ventilation or intermittent mandatory ventilation (IMV), is the medical term for using a machine called a ventilator to fully or partially provide artificial ventilation. Mechanical ventilation helps move air ...
in children. It can be used up to two years of age and is specified for children who are diagnosed with acute respiratory failure following exposure to a pathogen such as
RSV RSV may refer to: Biology and medicine * Respiratory syncytial virus, causing respiratory disease * Rous sarcoma virus, causing cancer in chickens Road vehicles * Several :Aprilia motorcycles, Aprilia motorcycles, e.g.RSV4 * Minicar RSV, a US saf ...
or
influenza Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms ...
, including H1N1. Lucinactant is also used to treat
meconium aspiration syndrome Meconium aspiration syndrome (MAS) also known as neonatal aspiration of meconium is a medical condition affecting newborn infants. It describes the spectrum of disorders and pathophysiology of newborns born in meconium-stained amniotic fluid (MSAF ...
.


Chemistry

Lucinactant contains the peptide sinapultide (KL4 acetate, ), dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol (as the sodium salt), and
palmitic acid Palmitic acid (hexadecanoic acid in IUPAC nomenclature) is a fatty acid with a 16-carbon chain. It is the most common saturated fatty acid found in animals, plants and microorganisms.Gunstone, F. D., John L. Harwood, and Albert J. Dijkstra. The Li ...
.


History

The scientific groundwork for lucinactant was laid in the laboratory of Charles Cochrane at The
Scripps Research Institute Scripps Research, previously known as The Scripps Research Institute (TSRI), is a nonprofit American medical research facility that focuses on research and education in the biomedical sciences. Headquartered in San Diego, California, the institu ...
in the 1990s. 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.


Legal status

Lucinactant is listed as an Orphan Drug Product by the US Food and Drug Administration for several conditions: * 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. 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.


References

{{Reflist Drugs acting on the respiratory system Pediatrics Respiratory and cardiovascular disorders specific to the perinatal period