Lucinactant Explained

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]

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.[3] [4] [5] Lucinactant is also used to treat meconium aspiration syndrome.[5] [6]

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.[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]

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.

Notes and References

  1. Web site: Surfaxin . https://web.archive.org/web/20090420135625/http://www.discoverylabs.com/surfaxin.html . April 20, 2009 . Discovery Labs .
  2. Web site: FDA approves Surfaxin to prevent breathing disorder in premature infants . Fda.gov . 2012-03-06 . 2012-10-20.
  3. News: POPG, a Key Component of Discovery Labs' KL4 Surfactant, Identified as a Novel Anti-Viral Therapeutic Approach . dead . https://web.archive.org/web/20100122205312/http://money.cnn.com/news/newsfeeds/articles/globenewswire/182115.htm . January 22, 2010 .
  4. Wiswell TE, Smith RM, Katz LB, Mastroianni L, Wong DY, Willms D, Heard S, Wilson M, Hite RD, Anzueto A, Revak SD, Cochrane CG . 6 . 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 . October 1999 . 10508806 . 10.1164/ajrccm.160.4.9808118 .
  5. Donn SM . 6843316 . Lucinactant: a novel synthetic surfactant for the treatment of respiratory distress syndrome . Expert Opinion on Investigational Drugs . 14 . 3 . 329–34 . March 2005 . 15833063 . 10.1517/13543784.14.3.329 .
  6. Wiswell TE, Knight GR, Finer NN, Donn SM, Desai H, Walsh WF, Sekar KC, Bernstein G, Keszler M, Visser VE, Merritt TA, Mannino FL, Mastrioianni L, Marcy B, Revak SD, Tsai H, Cochrane CG . 6 . A multicenter, randomized, controlled trial comparing Surfaxin (Lucinactant) lavage with standard care for treatment of meconium aspiration syndrome . Pediatrics . 109 . 6 . 1081–7 . June 2002 . 12042546 . 10.1542/peds.109.6.1081 .
  7. Web site: Scripps Research Discoveries Lead to Newly Approved Drug for Infant Respiratory Distress Syndrome . Scripps.edu . 2012-03-06 . 2012-10-20.
  8. Web site: Pharmaceutical News - Discovery Labs Turns Focus To Surfaxin Market Strategy - October 20, 2012 . Pharmacy Choice . 2012-10-20.
  9. Web site: List Of Orphan Products Designations And Approvals . Google2.fda.gov . 2012-10-20.
  10. Web site: US FDA grants "orphan drug" status for sinapultide (Surfaxin) for chronic lung disease in premature infants . Nelm.nhs.uk . 2012-10-20 . http://webarchive.nationalarchives.gov.uk/20100414230847/http%3A//www.nelm.nhs.uk/en/NeLM%2DArea/News/485098/485446/485460/ . 2010-04-14 . dead .
  11. Charatan F . Surfactant trial in Latin American infants criticised . BMJ . 322 . 7286 . 575 . March 2001 . 11238147 . 1119782 . 10.1136/bmj.322.7286.620 . 7286 .

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