The US Food and Drug Administration (FDA) approved yesterday the drug [removed]Surfaxin®[/removed] (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS. The drug was developed by The Scripps Research Institute, La Jolla, Calif, and Discovery Labs, Warrington, Pa.

"I am excited that our scientific findings will help save lives," said Charles Cochrane, MD, professor emeritus at Scripps Research. “Many years of work in our basic research laboratory at The Scripps Research Institute made this landmark development possible.”

In addition to mechanical ventilation, current treatments for preterm infants with RDS involve using animal-derived surfactants, which contain material that can be injurious to the lungs and cannot be produced in quantities sufficient to treat preterm infants worldwide. In addition, animal-derived surfactants can only be used once since they cause an immune reaction.

Surfaxin, however, is a synthetic surfactant, and, thus, not immunogenic.

The Cochrane lab first created a synthetic version of surfactant in the 1990s, mimicking a natural peptide known as Surfactant Protein B. Following on this work, the therapy was developed by Discovery Labs, which oversaw the three phases of clinical trials required by the FDA.

Discovery Labs expects Surfaxin to be available commercially in late 2012.

Source: The Scripps Research Institute; Discovery Labs