Discovery Laboratories Inc., of Warrington, Pa., has said that it plans to conduct additional preclinical work rather than conduct a limited clinical trial, to potentially gain FDA marketing approval for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants. Previously, the company had expected that a limited, pharmacodynamic (PD)-based clinical trial in preterm infants would be required to address the sole remaining chemistry, manufacturing and control issue involving the final validation of a fetal rabbit biological activity test. But the FDA has advised that a PD clinical trial approach is not appropriate. Compared to a PD clinical trial, a comprehensive preclinical program, if successful, could significantly reduce the time and expense required to gain potential Surfaxin approval, the company said. A complete response could be submitted to the FDA in the first quarter of 2011.
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