According to Windtree Therapeutics, its Aerosurf inhaled lucinactant for the treatment of premature infants with respiratory distress syndrome (RDS) has received Fast Track designation from the FDA.
Aerosurf is currently in Phase 2 development, with a Phase 2b clinical trial in premature infants receiving nasal continuous positive airway pressure (nCPAP) RDS underway. In August 2016, Windtree announced that it had received a grant worth up to $2.6 million for the Phase 2b trial.
Windtree President and CEO Craig Fraser commented, “This Fast Track designation for Aerosurf underscores the significant need to reduce the use of invasive intubation and mechanical ventilation, which are required to administer surfactant therapy, but may result in serious complications and increase the risk for other respiratory conditions. By enabling non-invasive delivery of our aerosolized KL4 surfactant, we believe that Aerosurf will address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits. We look forward to continuing our work with the FDA to advance Aerosurf through the clinical development and regulatory approval process, with the goal of bringing a transformative therapy to treat premature infants in an expedited time frame.”
Read the Windtree Therapeutics press release.
