Respiratory Distress Syndrome (RDS)
Our lead surfactant product candidate is SURFAXIN® (lucinactant), a liquid instillate
formulation of KL4 surfactant, which is currently approved by the U.S. Food and Drug
Administration (FDA) for the prevention of RDS in premature infants at high risk for RDS.
We are also developing product solutions for RDS through a variety of dosage forms, including SURFAXIN LSTM,
a lyophilized formulation of KL4 surfactant, as well as AEROSURF®,
an aerosolized KL4 surfactant.
AEROSURF could represent a transformational change in neonatal respiratory critical care by
providing practitioners the ability to administer surfactants using less invasive means. By potentially reducing or eliminating complications
associated with endotracheal intubation and mechanical ventilation, AEROSURF may also support a potentially significant increase in the number
of infants with or at risk for RDS who could benefit from surfactant therapy.
Additional Respiratory Applications
We also believe that KL4 surfactant surfactant may have application in the spectrum of
respiratory critical care disorders, which includes acute respiratory failure (ARF) and acute lung injury (ALI). We plan to explore these areas
once we have secured appropriate capital, which may be accomplished through strategic alliances or other collaborative arrangements.
Aersolized Drug Delivery
Discovery Labs’ lead drug delivery product is AFECTAIR, a series of novel ventilator circuit/patient
interface connectors, the initial version of which has been registered as a Class I, exempt medical device in the U.S. We are also pursuing the
registration of AFECTAIR in the European Union and other non-U.S. jurisdictions.
We plan to initiate the commercial introduction of the initial AFECTAIR devices in the United
States and the European Union in 2012.
Additional Drug Delivery Applications
Discovery Labs is also advancing its proprietary capillary aerosol generator (CAG) as part of its
AEROSURF development program. The CAG has been designed to
produce high volume, low-velocity aerosolized KL4 surfactant for intra-pulmonary delivery for
the prevention and/or treatment of RDS in premature infants, but may have other applications in the
advancement of a new standard for respiratory critical care.
IMPORTANT SAFETY INFORMATION
SURFAXIN (lucinactant intratracheal suspension) is intended for intratracheal use only. The administration of exogenous surfactants,
including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and
experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting.
Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond
to changes in respiratory status. Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor,
endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation, endotracheal tube reflux,
or airway obstruction occurs, administration should be interrupted and the infant’s clinical condition assessed and stabilized. SURFAXIN is not indicated for
use in acute respiratory distress syndrome (ARDS).
AEROSURF is an investigational drug-device combination product not approved by the FDA.
The initial AFECTAIR device has been registered with the FDA, but is not commercially available at this time.