The Food and Drug Administration (FDA) has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.

Aerosurf is an investigational drug/device product that combines Windtree’s proprietary aerosolized KL4 surfactant with its novel aerosol delivery system (ADS) based primarily on its capillary aerosol generator technology. Aerosurf is under development for the noninvasive administration of surfactant therapy to premature infants with RDS with the potential to reduce the need for invasive endotracheal intubation and mechanical ventilation.

Windtree Therapeutics is currently evaluating Aerosurf in a multinational, Phase 2b clinical trial in premature infants 26 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS.

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