A 1991 paper by Dechant and Faulds noted that in a large clinical trial, babies diagnosed with respiratory distress syndrome who were treated with Exosurf had fewer pneumothoraces, and survivors had less incidence of bronchopulmonary dysplasia.
Although Exosurf was one of the important early protein-free non-biological surfactant preparations of the 1980s, it was later withdrawn from the U.
Four large (several hundred in each group), prospective randomized clinical trials comparing Exosurf
(synthetic, no apoproteins) to Survanta (beractant) and to Infasurf (calfactant) have been conducted.
Products available in the United States include Exosurf
, a synthetic product, and Survanta, which is derived from cows' lungs.
The new drug, Exosurf Neonatal for intertracheal suspension, is expected to fulfill an immediate need as an estimated 50,000 infants develop RDS each year, according to Burroughs Wellcome Co.
A single dose of Exosurf reduces the chance of death from RDS by 50% immediately after birth and by 33% after one year, according to clinical data.
The company reports that because Exosurf is completely synthethic there is little potential for viral contamination or the harmful effects of nonhuman proteins.
(colfosceril palmitate), which was the only synthetic surfactant on the market, has been removed.