FDA nod for Discovery Labs Surfaxin for RDS

US specialty drugmaker Discovery Laboratories (Nasdaq: DSCO) saw its shares rocker 30% to $4.88 in after-hours trading yesterday, after the Food and Drug Administration approved its Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.

Surfaxin is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine, and Discovery Labs anticipates that the product will be commercially available in the USA in late 2012. Surfaxin, which was granted orphan drug status in 2006 but has previously been rejected by the FDA several times (The Pharma Letter April 21, 2009), becomes the fifth drug approved in the USA to treat RDS in premature infants. The other FDA-approved surfactants include Survanta (beractant), Curosurf (poractant alpha), Infasurf (calfactant), and Exosurf (colfosceril palmitate), which is no longer marketed, the agency noted.

"The approval of Surfaxin is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS," said Thomas Amick, chairman and chief executive of Discovery Labs, adding: "This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care."