Discovery Laboratories Inc, Warrington, Pa, has received US Food and Drug Administration (FDA) clearance to market AFECTAIR® in the United States. AFECTAIR is a disposable ventilator circuit/patient interface connector for the delivery of aerosolized medications to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.
AFECTAIR originated from the Discovery Laboratories AEROSURF® development program. AEROSURF, an aerosolized KL4 surfactant product, is under development for the prevention of respiratory distress syndrome in premature infants.
According to the company, in vitro studies to date suggest that AFECTAIR technology “may be an effective new solution for delivering aerosolized medicine to patients receiving ventilator support while providing health care professionals with a simplified alternative to current practices.”
Discovery Labs is also pursuing a European Community (CE) marking for commercialization of the initial AFECTAIR products in the European Union. The company believes it may be in a position to begin commercial introduction of the initial AFECTAIR products in Europe in late 2012.
Source: Discovery Laboratories Inc