Surfaxin
Encyclopedia
Surfaxin is a liquid medication used to treat Infant Respiratory Distress Syndrome
in infants. It is currently under investigation by the FDA and not licensed for general use.
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. Surfaxin is also used to treat meconium aspiration syndrome
.
by the US Food and Drug Administration for several conditions:
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.
Infant respiratory distress syndrome
Infant respiratory distress syndrome , also called neonatal respiratory distress syndrome or respiratory distress syndrome of newborn, previously called hyaline membrane disease, is a syndrome in premature infants caused by developmental insufficiency of surfactant production and structural...
in infants. It is currently under investigation by the FDA and not licensed for general use.
History
Surfaxin was denied full FDA approval in April 2009, citing concerns over Surfaxin biological activity test. Surfaxin is currently under review by the FDA and the target action date is March 6, 2012.Indications
Surfaxin is indicated to improve lung function and reduce duration and risk of mechanical ventilationMechanical ventilation
In medicine, mechanical ventilation is a method to mechanically assist or replace spontaneous breathing. This may involve a machine called a ventilator or the breathing may be assisted by a physician, respiratory therapist or other suitable person compressing a bag or set of bellows...
in children. It can be used up to two years of age and is specified for children who are diagnosed with Acute Respiratory Failure
Respiratory failure
The term respiratory failure, in medicine, is used to describe inadequate gas exchange by the respiratory system, with the result that arterial oxygen and/or carbon dioxide levels cannot be maintained within their normal ranges. A drop in blood oxygenation is known as hypoxemia; a rise in arterial...
following exposure to a pathogen such as RSV or influenza, including H1N1. Surfaxin is also used to treat meconium aspiration syndrome
Meconium aspiration syndrome
Meconium aspiration syndrome is a medical condition affecting newborn infants. It occurs when meconium is present in their lungs during or before delivery...
.
Legal status
Surfaxin is listed as an Orphan Drug ProductOrphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
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.