Discovery Laboratories has submitted an investigational new drug (IND) application for its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, the company has announced. Assuming the FDA review proceeds without objection, the company says, enrollment in a planned Phase 2 study could be initiated in the 4th quarter of this year.
All of the currently marketed respiratory surfactants are liquid instillate formulations that require intubation for delivery. Aerosurf allows for delivery without intubation and is delivered by a proprietary capillary aerosol generator licensed from Philip Morris in conjunction with Discovery Lab’s Afectair ventilator circuit/patient interface connector. The Afectair device was approved in the US in early 2012.
Discovery Labs CEO John G. Cooper said, “The filing of our Aerosurf IND with the FDA represents an important milestone for our company and a first step towards a potentially transformational medical advancement for the neonatology community and the infants they care for.”
Read the Discovery Labs press release.
