Surfaxin, a program from Discovery Laboratories and to which ESTEVE has selected commercial rights, is a synthetic pulmonary surfactant recently approved by the US FDA for use in the prevention of Respiratory Distress Syndrome (RDS) in prematurely born infants.
Surfaxin is the result of a new surfactant technology which is designed to closely mimic the natural properties of a human lung surfactant. This enables the development of respiratory therapies for the treatment of life-threatening respiratory diseases prevalent in the neonatal intensive care unit, where there are few or no approved therapies available.
Two Phase III clinical trials (with 1294 patients and 252 patients) have demonstrated clinically meaningful survival and morbidity-lessening advantages versus the current standard of care. In addition, Surfaxin is listed as an Orphan Drug Product by the FDA for the treatment of Respiratory Distress Syndrome (RDS) in premature infants and by the EMA for the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants.