WARRINGTON, Pa., April 27, 2009 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that it presented a pharmacoeconomic analysis of data from its SELECT and STAR Phase 3 clinical trials for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at the 2009 International Congress on Clinical Pharmacy in Orlando, Florida. The analysis shows that in-hospital costs are higher for infants who require reintubation after surfactant administration and successful extubation when compared with infants who do not require reintubation. The presentation also included previously-reported data demonstrating that infants treated with Surfaxin in the SELECT and STAR trials required less reintubation compared with infants treated with currently available animal-derived surfactants.
The pharmacoeconomic analysis was conducted on 1,546 infants who were treated with Surfaxin, Exosurf(r), Survanta(r), or Curosurf(r). After initial surfactant treatment and successful extubation, infants either remained extubated through 36 weeks post-menstrual age or required reintubation. The results showed that infants who were reintubated required overall significantly more days on mechanical ventilation (p<0.001) and experienced longer Neonatal Intensive Care Unit (NICU) stays (p=0.017) than infants who were not reintubated. Based on the average costs associated with additional days on mechanical ventilation and prolonged NICU stay, infants who required reintubation were estimated to increase the overall hospital cost by more than $33,000 per child.
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, followed by 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.
Dr. Robert Segal, Senior Vice President and Chief Medical Officer of Discovery Labs commented, "In infants with RDS, NICU stays and mechanical ventilation consume significant hospital resources, including nursing and respiratory care, and radiology and pharmacy costs. This analysis of data from our Phase 3 clinical trials is important because it indicates that reintubation significantly increases the costs of treating these infants. Our clinical experience suggests that Surfaxin significantly reduces the frequency of reintubation and therefore is likely to reduce the overall costs of NICU stays for premature infants. Therapies capable of improving survival and outcomes while reducing complications of prematurity and related hospital costs could represent a potentially significant advancement in neonatal care."
Previously presented results showed that 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. In addition, infants treated with Surfaxin had significantly lower reintubation rates and higher rates of survival without reintubation compared with infants treated with animal-derived surfactants in the Surfaxin Phase 3 RDS clinical trials.
Surfaxin is a synthetic, peptide-containing, surfactant that is structurally similar to pulmonary surfactant, a substance produced naturally in human lungs and is essential for breathing. Surfaxin represents a potential alternative to the currently-available animal-derived surfactants. Surfaxin is an investigational product that has not been approved by the U.S. FDA or any other world health regulatory authorities. The data listed above include information that may be of interest to healthcare practitioners; however, the clinical relevance of this information has not been fully established.
About the 2009 International Congress on Clinical Pharmacy
The 2009 International Congress on Clinical Pharmacy is held every five years and allows clinical pharmacists from around the world to come together to exchange new knowledge and best practices and discuss global health care issues. Participating organizations include the American College of Clinical Pharmacy (ACCP), the European Society for Clinical Pharmacy (ESCP), and the Pediatric Pharmacy Advocacy Group (PPAG). The congress hosts nearly 2000 pharmacists from North America and Europe.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 Surfactant Technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary Capillary Aerosolization Technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration.
Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children. For more information, please visit our website at www.Discoverylabs.com.
Forward Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto, which the reader is encouraged to read.