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SURFAXIN LSTM is a lyophilized (dry powder) formulation of KL4 Surfactant intended to improve the convenience of product use for healthcare practitioners, eliminate the need for cold-chain storage, and potentially further improve product clinical performance. The lyophilized product is intended to be reconstituted with sterile water and administered, like SURFAXIN® liquid instillate and current surfactants, into the endotracheal tube (ETT) of a mechanically ventilated patient. SURFAXIN LSTM has the potential, over time, to displace the animal-derived products and significantly increase the total market value of ETT delivered surfactants above the current global market of approximately $200 million.
On October 5th 2013 the U.S. Food and Drug Administration (FDA) has agreed to the Discovery Labs updated product specifications for SURFAXIN® (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Discovery Labs has initiated manufacturing of SURFAXIN for its planned commercial introduction in the fourth quarter of 2013. SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants and the only approved alternative to animal-derived surfactants currently used today.