FDA approved Exosurf
Neonatal, Survanta, Surfactant TA, Human Surf and Dey Lab's lung surfactants respectively.
In the study, the infants were treated with lucinactant (Surfaxin), colfosceril palmitate (Exosurf
), or beractant (Survanta) within 30 minutes of birth.
One of the first available protein-free, artificial surfactant preparations was Exosurf, or colfosceril palmitate plus cetyl alcohol and tyloxapol.
Although Exosurf was one of the important early protein-free non-biological surfactant preparations of the 1980s, it was later withdrawn from the U.S.
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.
Lucinactant patients showed an RDS mortality (25 of 527, 4.7%) that was 4.7% and 5.8% lower than Exosurf (48 of 510, 9.4%, P = 0.005) and beractant (27 of 258, 10.5%, P = 0.001), respectively.
Products available in the United States include Exosurf
, a synthetic product, and Survanta, which is derived from cows' lungs. Additional research is necessary to determine which type of surfactant is best and if either causes any long-term effects.
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., Exosurf's manufacturer.
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.