Dear Healthcare Provider,
Above most, you understand the
potential challenges that lie ahead for an infant that is born
prematurely. Your goal is to ensure each
infant has the quality of life her parents long for and which she deserves. You also know that not all medications are
created equal. That is why, according to
a recent publication in the Journal of
Neonatal-Perinatal Medicine; nearly all neonatologists interviewed stated
they were concerned about the exposure of newborn infants to animal-derived
medications.1
In March, the US FDA approved
the first and only synthetic peptide-containing surfactant, SURFAXIN®
(lucinactant). Approved for the
prevention of respiratory distress syndrome (RDS) in premature infants at high
risk for RDS, SURFAXIN is the first new alternative to animal-derived
surfactants to be approved by the FDA in more than two decades. Importantly, the safety and efficacy of
SURFAXIN was evaluated in two phase 3 clinical trials2,3, which
included direct comparisons to the animal-derived surfactants, Survanta®
and Curosurf®. SURFAXIN will
become available as a commercial product later this year.
The approval of SURFAXIN
represents more than just a therapeutic alternative for neonatologists and NICU
parents. It is the embodiment of the unwavering commitment Discovery Labs has
to the respiratory critical care community today and tomorrow. We have
persisted because of our belief in the series of new solutions that we are
developing to improve patient lives and the standard of respiratory critical
care.
As you contemplate the best
treatment options for your neonatal patients, we would be happy to provide you
with more information about SURFAXIN and explore ways to work together to
alleviate the concerns of neonatologists and NICU parents who have waited for
more than a decade for a new and effective alternative for the prevention of
RDS in preterm infants.
Together, we can reach our goal
of redefining RDS management and give preterm infants the life they deserve.
Sincerely,
Dr. Thomas F. Miller
Chief Operating Officer
Discovery Laboratories, Inc.
Warrington, PA
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).
Please
click here for full prescribing information or
visit www.surfaxin.com.
1 S. Sarkar and S.M. Donn, Journal of Neonatal-‐Perinatal Medicine 4 (2011) 235–239
2 F. R. Moya, et al; Pediatrics 2005;115;1018-‐1029
3 S. K. Sinha, et al; Pediatrics 2005;115;1030-‐1038