The US FDA has accepted Discovery Laboratories' resubmission of October 5, 2005 as a complete response to the approvable letter for Surfaxin, for the prevention of respiratory distress syndrome (RDS) in premature infants. The FDA has established April 2006 as its target to complete its review of the Surfaxin new drug application (NDA).
Robert J. Capetola, president and chief executive officer of Discovery, stated, "With the acceptance of our response to the Surfaxin approvable letter, the FDA six-month review process has begun as of October 5, 2005, the date of our resubmission. Discovery will work diligently with the FDA during this review, which will include the reinspection of our Surfaxin contract manufacturing facility, Laureate Pharma in Totowa, New Jersey. We anticipate that Surfaxin, the first precision-engineered Surfactant Replacement Therapy, will be available to the neonatal medical community in the second quarter of 2006."
Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative for the animal-derived and non-protein containing synthetic surfactants.
According to a company release, Discovery's Surfaxin has received an approvable letter from the FDA for the prevention of RDS in premature infants and is pending approval. Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and to maintain proper airflow through the respiratory system. Premature babies are born with a lack of natural surfactant in their lungs. Without surfactant, the air sacs in the lungs collapse and are unable to absorb sufficient oxygen resulting in RDS.
Discovery Laboratories Inc. is a biotechnology company developing its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory diseases. Discovery's technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human ling surfactant.