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Respiratory Distress Syndrome (RDS)
Our lead pipeline drug programs,
SURFAXIN®, SURFAXIN LSTM, and
AEROSURF®, are focused on addressing the most significant respiratory condition
affecting premature infants, respiratory distress syndrome (RDS). RDS is one of the most common, life-threatening pediatric respiratory disorders,
with more than 500,000 low-birth-weight premature infants at risk globally each year. Premature infants with RDS are currently treated with surfactants
that are administered by means of invasive endotracheal intubation and mechanical ventilation. Although necessary for the administration of surfactant,
these procedures can result in other serious complications beyond RDS. As a consequence, many neonatologists will only intubate and administer surfactant
in cases of severe respiratory distress, where the benefits of invasive surfactant administration clearly outweigh the associated risk.
Currently, the surfactants predominantly used throughout most of the world, including the U.S., are animal-derived. Due to their inherent limitations,
these surfactants have only been developed and approved for endotracheal tube administration for RDS. We believe that the neonatal medical community increasingly
recognizes the potential benefits of a synthetic peptide-containing surfactant and, more importantly, the possibility that this technology creates for a
less-invasive method of delivering surfactant to treat premature infants suffering from respiratory disorders.
SURFAXIN (lucinactant) is an investigational drug, and is under review by the U.S. Food & Drug Administration (FDA). Several published
and presented pre-clinical and clinical studies are referenced throughout this website; however, approved and final prescribing information for SURFAXIN is not
available at this time.
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