WARRINGTON, Pa., June 8, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announces today that it has received written guidance from the U.S. Food and Drug Administration (FDA) that is consistent with its ongoing, comprehensive preclinical program to resolve the sole remaining chemistry, manufacturing & control (CMC) issue necessary to potentially gain FDA marketing approval for Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a Phase 3 clinical program. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine. Discovery Labs believes it remains on track to complete the preclinical program and submit its Complete Response to the FDA in the first quarter of 2011.
