Nov. 8, 2013
/PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that it has initiated the U.S. commercial launch of SURFAXIN
(lucinactant) Intratracheal Suspension for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant and the only alternative to animal-derived surfactants available in the U.S.
"The commercial launch of SURFAXIN marks a significant milestone for Discovery Labs, but more importantly represents a long-awaited therapeutic option for the neonatology community and the fragile premature infants in its care," said
John G. Cooper
, Chief Executive Officer of Discovery Labs.
Discovery Labs also announced today that, in accordance with the terms of its
$30 million secured loan facility with Deerfield Management Company, L.P. (
), it will be notifying
that it has now met the conditions to receive the final $20 million advance under the facility. Upon receipt of the
advance in early
, the Company will issue warrants to
for approximately 4.7 million shares at an exercise price of
The U.S. Food and Drug Administration (FDA) approved SURFAXIN
(lucinactant) Intratracheal Suspension for the prevention of RDS in premature infants who are at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants in the U.S.
IMPORTANT SAFETY INFORMATION
SURFAXIN 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).