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.
Dr. Thomas F. Miller
Chief Operating Officer
Discovery Laboratories, Inc.
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).
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