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April 15, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the U.S. Food and Drug Administration (FDA) has requested clarification and provided recommendations regarding the recently-updated product specifications for SURFAXIN
®. Discovery Labs plans to provide a response to the FDA within two months. FDA procedure provides up to four months for FDA review of 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 validated the analytical chemistry method, and submitted updated product specifications to the FDA.
The recently-received FDA correspondence includes a request for specific information intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method, including:
Recommendations regarding how the product specifications should be documented and notated
A specific recommendation for the upper limit of a single product specification that Discovery Labs can readily accept
A request for two existing and readily available documents related to the improved analytical chemistry method
Request for supporting data using the recently improved and revalidated analytical chemistry method that is being generated from recent SURFAXIN batches.
"We appreciate the FDA's recommendations," said Dr.
Russell G. Clayton, Senior Vice President, Research & Development, at Discovery Labs. "Our team is compiling the information and we will continue to communicate with the FDA to ensure our response meets its needs."
Discovery Labs believes that its product portfolio and development pipeline based on KL
4 surfactant and aerosol delivery technologies can bring transformational improvements to neonatal respiratory critical care. The current improvement and validation of the analytical chemistry method used to assess specification conformance for SURFAXIN drug product has no technical impact on the AEROSURF
® program. The AEROSURF program currently remains on track for the phase 2 clinical program in the fourth quarter of 2013.
"We are committed to SURFAXIN, AFECTAIR
® and AEROSURF with the goal of building a specialized biotechnology company that has the potential to establish new standards in respiratory critical care, beginning with neonatology," said
John G. Cooper, President and Chief Executive Officer at Discovery Labs. "As we address the FDA's recommendations on SURFAXIN, we will also assess various strategic and financial alternatives to support the execution of our fundamental strategy."
ABOUT SURFAXINSURFAXIN (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 INFORMATIONSURFAXIN (lucinactant) intratracheal suspension 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. SURFAXIN is not indicated for use in acute respiratory distress syndrome (ARDS).