Discovery Laboratories, Inc announced that a new analysis of data from its SELECT and STAR phase-3 clinical trials for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants was presented at the American Association for Respiratory Care (AARC) International Respiratory Congress. In these studies, premature infants with RDS treated with surfactant and subsequently requiring reintubation had a significantly higher rate of mortality. As previously reported, premature infants treated with Surfaxin required less reintubation as compared with those treated with the animal-derived surfactants, Survanta and Curosurf.

Premature infants are often born with a lack of natural lung surfactant and are unable to absorb sufficient oxygen, resulting in RDS. The current standard treatment for RDS typically requires that the infant be intubated (insertion of a breathing tube into the infant's airway) to allow for respiratory support via mechanical ventilation and surfactant administration. If therapy is successful, the breathing tube is removed from the infant's airway (extubation) to allow the infant to breathe spontaneously. Many infants have difficulty breathing spontaneously after the initial extubation and require reintubation.

Data from Discovery Labs' phase-3 clinical trials in RDS were analyzed to evaluate reintubation rates and clinical outcomes.

Infants who were successfully extubated and did not require reintubation experienced low mortality rates across all treatment groups (0-1% range), while infants who were extubated and subsequently reintubated had a statistically significant higher mortality rate (0.5% vs. 17.65%, respectively; p less than 0.05).

Infants treated with Surfaxin demonstrated a significantly lower reintubation rate as compared with those infants treated with animal-derived surfactants, Curosurf (33% vs. 47%; p less than 0.05) and Survanta (35% vs. 43%; p less than 0.05).

Infants treated with Surfaxin demonstrated a significantly higher combined outcome of survival without reintubation as compared with those infants treated with animal-derived surfactants, Curosurf (67% vs. 53%; p less than 0.05) and Survanta (65% vs. 57%; p less than 0.05).

Dr Robert Segal, senior vice president and chief medical officer of Discovery Labs commented, "Premature infants with RDS are currently treated with surfactants derived from bovine and porcine sources. This new analysis of data from our phase-3 clinical trials is important because it suggests that Surfaxin decreases reintubation frequency when compared with current standard of care. Therapies capable of improving survival while reducing complications of prematurity could represent a potentially significant advancement in neonatal care."

Surfaxin is an investigational drug for the prevention of RDS in premature infants. A New Drug Application for Surfaxin is under review by the US FDA with a target date of April 17, 2009 for potential marketing approval. Surfaxin is a synthetic, peptide-containing, surfactant that is structurally similar to pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing.

Surfaxin represents a potential alternative to the currently-available animal-derived surfactants. AARC is the leading national and international professional association for respiratory care.

Discovery Labs is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases.