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Discovery Laboratories announced Tuesday that it responded to an FDA complete response letter issued over Surfaxin (lucinactant), the company’s experimental drug for the prevention of respiratory distress syndrome in premature infants. "We have had several productive interactions with the FDA related to our Surfaxin comprehensive preclinical program to support the complete response," commented CEO W. Thomas Amick.

In the letter, which was issued in 2009, the agency asked the drugmaker to provide additional information related to a pre-clinical stage quality control release and stability test for the experimental therapy. At the time, the FDA did not ask for additional clinical trials, but Discovery provided data from a completed comprehensive preclinical programme in the submission.

Discovery indicated that it expects its response to be designated as a Class 2 resubmission, suggesting that a decision on the drug could be issued in the first quarter of next year.
If approved, the drugmaker noted that Surfaxin would be the first synthetic, peptide-containing surfactant for use in neonatal medicine.

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