Lucinactant (trade name Surfaxin) is a liquid medication used to treat infant respiratory distress syndrome. It was approved for use in the United States by the U.S. Food and Drug Administration (FDA) on March 6, 2012.
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.
Physical and chemical properties
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.
- 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.
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