Discovery Laboratories Submits SURFAXIN Pharmacodynamic Trial Protocol to FDA

WARRINGTON, Pa., Nov. 17, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) its proposed protocol for a Surfaxin(R) (lucinactant) limited clinical trial. The protocol incorporates a clinical trial design that is primarily intended to assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with Respiratory Distress Syndrome (RDS). Discovery Labs proposed this trial design in response to a comment by the FDA that a limited clinical trial could potentially resolve the key remaining issue for approval of Surfaxin for the prevention of RDS in premature infants.