June 10, 2013
/PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that on June 7,
2013 it submitted a response to the U.S. Food and Drug Administration's (FDA) recent correspondence relating to Discovery Labs' recently updated product specifications for SURFAXIN
. Discovery Labs expects that the FDA may take up to four months to review the information provided. If its plan is successful and the FDA agrees with the response, Discovery Labs expects to proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013.
In the third quarter of 2012, during a routine review of the results and processes related to the analytical testing and quality control of SURFAXIN drug product, Discovery Labs determined that one of its analytical chemistry methods used to assess SURFAXIN drug product conformance to specifications required improvement and that an update to product specifications was necessary. The Company proactively communicated these findings to the FDA, improved and revalidated the analytical chemistry method, and submitted updated product specifications to the FDA. Subsequently, the FDA requested information and provided recommendations intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method. Discovery Labs has now responded to the FDA's request.
Improvement of the method and the proposed change in SURFAXIN product specifications is expected to have no impact on Discovery Labs' development programs, including AEROSURF
. The AEROSURF program currently remains on track for the initiation of phase 2 clinical program in the fourth quarter of 2013.
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.
IMPORTANT SAFETY INFORMATION
SURFAXIN is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized.