March 6, 2012
/PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the United States Food and Drug Administration (FDA) has approved 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. Discovery Labs anticipates that SURFAXIN will be commercially available in
the United States
in late 2012.
"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
W. Thomas Amick
, Chairman of the Board and Chief Executive Officer of Discovery Labs. "This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care."
RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in
the United States
are treated annually with currently available animal-derived surfactants.
Discovery Labs will hold a conference call tomorrow,
March 7th, 2012
10:00 a.m. EST
to further discuss the foregoing. The call in number is (877) 215-0093. The international call in number is (706) 679-3237. The passcode is 58400332. This audio webcast will be available through a live broadcast on the Internet at
. The replay number to hear the conference call is (855) 859-2056 or (404) 537-3406 using the same conference call password listed above.
SURFAXIN (lucinactant intratracheal suspension) is a synthetic, peptide-containing surfactant. SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. Discovery Labs anticipates that SURFAXIN will be commercially available in late 2012.