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Mar 7, 2012

FDA Clears Discovery Laboratories’ Drug for Respiratory Distress Syndrome in Infants

  • FDA approved Discovery Laboratories Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in at risk premature infants. The drug comprises a synthetic peptide surfactant, KL4 (sinapultide), which mimics the activity of lung surfactant protein SP-B.

    Approval of Surfaxin in the U.S. was based on data from two Phase III studies. One compared the safety and efficacy of Surfaxin with the non-protein-based synthetic surfactant Exosurf™ and animal-based Survanta®. The second compared Surfaxin with the porcine derived surfactant Curosurf®.

    Data from the pivotal Select study in 1294 patients found that Surfaxin treatment improved 14-day RDS-related mortality in comparison with Survanta and Exosurf, and also improved RDS at 24 hours when compared with Exosurf. Surfaxin-treated infants also required fewer reintubations than those treated with Survantin. Data from supportive Phase III Star study confirmed the non-inferiority of Surfaxin compared with Curosurf in terms of survival without BPD. Surfaxin therapy was also associated with fewer reintubations, and the Surfaxin an improved one-year survival profile.  

    The Surfaxin technology originates from research at the Scripps Research Institute, which first created a synthetic mimic of SP-B back in the 1990s. The Institute claims that existing animal-derived surfactants are expensive, and can’t be produced in quantities sufficient to treat pre-term infants worldwide. Animal-derived surfactants can in addition only be used once as they cause an immune reaction. In contrast, The synthetic Surfaxin surfactant is nonimmunogenic.

    Discovery Laboratories is focused on the development of respiratory critical care technologies. The firm’s pipeline is based on its KL4 surfactant technology, and its Capillary Aersolo generate (CAG) platform for the delivery of aerosolized respiratory drugs, including the KL4 surfactant. The firm is in addition developing a lyophilized formulation of Surfaxin, to negate the requirement of cold-chain storage and improve ease of use. 


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