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Trials & Filings

Discovery Labs Files IND for Aerosurf

Plans Phase II trial of aerosolized surfactant for infant RDS

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Discovery Laboratories has submitted an IND to the FDA to initiate its Phase II clinical program for Aerosurf. The FDA has confirmed receipt of the IND and has indicated that, unless otherwise notified during its review, the company may initiate the program after a 30-day period. Discovery Labs may begin patient enrollment could in 4Q13.

Aerosurf is a novel investigational drug-device combination product being developed to deliver Discovery Labs’ KL4 surfactant in aerosolized form to premature infants with respiratory distress syndrome (RDS). Aerosurf could potentially allow for the administration of KL4 surfactant to premature infants without invasive endotracheal intubation, and may enable the treatment of a significantly greater number of premature infants who could benefit from surfactant therapy but are currently not treated.

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