Lucinactant

Medical uses

Lucinactant is indicated to improve lung function and reduce duration and risk of mechanical ventilation 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 or influenza, including H1N1. Lucinactant is also used to treat meconium aspiration syndrome.

Chemistry

Lucinactant contains the peptide sinapultide (KL4 acetate, ), dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol (as the sodium salt), and palmitic acid.

History

The scientific groundwork for lucinactant was laid in the laboratory of Charles Cochrane at The Scripps Research Institute 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

References

1. "Surfaxin". Discovery Labs.
2. (2012-03-06). "FDA approves Surfaxin to prevent breathing disorder in premature infants". Fda.gov.
3. (October 1999). "Bronchopulmonary segmental lavage with Surfaxin (KL(4)-surfactant) for acute respiratory distress syndrome". American Journal of Respiratory and Critical Care Medicine.
4. (March 2005). "Lucinactant: a novel synthetic surfactant for the treatment of respiratory distress syndrome". Expert Opinion on Investigational Drugs.
5. (June 2002). "A multicenter, randomized, controlled trial comparing Surfaxin (Lucinactant) lavage with standard care for treatment of meconium aspiration syndrome". Pediatrics.
6. (2012-03-06). "Scripps Research Discoveries Lead to Newly Approved Drug for Infant Respiratory Distress Syndrome". Scripps.edu.
7. "Pharmaceutical News - Discovery Labs Turns Focus To Surfaxin Market Strategy - October 20, 2012". Pharmacy Choice.
8. "List Of Orphan Products Designations And Approvals". Google2.fda.gov.
9. "US FDA grants "orphan drug" status for sinapultide (Surfaxin) for chronic lung disease in premature infants". Nelm.nhs.uk.
10. (March 2001). "Surfactant trial in Latin American infants criticised". BMJ.