Discovery Labs, Inc. announced that, on September 2, 2011, it submitted its Complete Response to the 2009 Complete Response Letter issued by the US Food and Drug Administration (FDA) for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.
Discovery Labs believes that the FDA will designate the Complete Response as a Class 2 resubmission of the Surfaxin New Drug Application (NDA), which would result in a target review period of six months and potential approval of Surfaxin in the first quarter of 2012. If approved, Surfaxin would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine.
In April 2009, Discovery Labs received from the FDA a Complete Response Letter, which contains the requirements that must be addressed to gain US marketing approval for Surfaxin . The safety and efficacy of Surfaxin for the prevention of RDS in premature infants has been previously demonstrated in a large, multinational phase 3 clinical programme. The Complete Response Letter did not question the quality of the clinical trial data or call for additional clinical trials to demonstrate the safety or efficacy of Surfaxin . The Complete Response Letter focused primarily on certain aspects of an important quality control release and stability test for Surfaxin , the fetal rabbit biological activity test (BAT). Discovery Labs believes that a key step to potentially gain FDA marketing approval for Surfaxin is to satisfy the FDA's requirements for final validation of the BAT. Accordingly, Discovery Labs has completed a comprehensive preclinical program intended to meet the FDA's requirements and has included these data in its Complete Response.
"We have had several productive interactions with the FDA related to our Surfaxin comprehensive preclinical program to support the Complete Response," said W. Thomas Amick, chairman of the board and chief executive officer, Discovery Labs. "Based on these interactions, we believe we have addressed all requirements of the 2009 Complete Response Letter."
In accordance with FDA guidance, Discovery Labs expects that it will be notified within 14 days that the Complete Response is deemed "complete" and the classification of the submission, which, under the Prescription Drug User Fee Act, will determine the target action date (PDUFA date) for the FDA to complete its review of the Surfaxin NDA. Upon receipt of this notification, Discovery Labs plans to hold an investor conference call to provide an overview of the comprehensive preclinical programme and the Surfaxin Complete Response.