FDA Approved Drugs » 2012
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Discovery Laboratories
Approval Status: Approved March 2012
Treatment Area: respiratory distress syndrome in premature infants
Surfaxin (lucinactant) is a synthetic formulation of pulmonary surfactant. Endogenous pulmonary surfactant lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in respiratory distress syndrome (RDS). Surfaxin compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.
Surfaxin is specifically indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
Surfaxin is supplied as a solution for intratracheal administration. The recommended dose of Surfaxin is 5.8 mL per kg birth weight. Up to four doses of Surfaxin can be administered in the first 48 hours of life. Doses should be given no more frequently than every six hours.
FDA ApprovalThe FDA approval of Surfaxin was based on a single randomized, double-blind, multicenter, active-controlled, multi-dose study involving 1,294 premature infants in Europe and Latin America. The infants weighed between 600 g and 1,250 g at birth and were 32 weeks or less in gestational age. Within the first 30 minutes after birth, infants were randomized to receive one of three surfactants, Surfaxin (5.8 mL per kg), colfosceril palmitate (5.0 mL per kg) or beractant (4.0 mL per kg). Infants in the Surfaxin and beractant groups could be given up to three additional doses between six and 24 hours of birth, as often as every six hours, if they subsequently developed RDS and required mechanical ventilation. Infants in the colfosceril palmitate group could receive up to two additional doses at least 12 hours apart if they met the retreatment criteria. Some infants received placebo air to maintain blinding of the study. All doses were calculated based on birth weight. Infants were followed through 12-months corrected age. Co-primary endpoints were the incidence of RDS at 24 hours and RDS-related mortality at 14 days, with the intent of demonstrating superiority over colfosceril palmitate. Beractant served as an additional active comparator. Compared to colfosceril palmitate, Surfaxin demonstrated a statistically significant improvement in both RDS at 24 hours (39% versus 47%) and RDS-related mortality through Day 14 (5% versus 9%).
Adverse events associated with the use of Surfaxin may include, but are not limited to, the following:
Surfaxin (lucinactant) is a non-pyrogenic pulmonary surfactant. It is a synthetic formulation consisting of phospholipids, a fatty acid, and sinapultide (KL4 peptide), a 21-amino acid hydrophobic synthetic peptide. Endogenous pulmonary surfactant lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in RDS. Surfaxin compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.
Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A, Kornacka MK, Merritt TA, Segal R, Schaber CJ, Tsai H, Massaro J, d'Agostino R; International Surfaxin Collaborative Study Group A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants. Pediatrics 2005 Apr;115(4):1018-29
For additional information regarding Surfaxin or respiratory distress syndrome in premature infants, please visit the Discovery Labs web page.
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