FDA approves first synthetic, peptide-containing surfactant for prevention of RDS

FDA has approved lucinactant (Surfaxin, Discovery Labs) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. Surfaxin is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine.

Discovery Labs anticipates that Surfaxin will be commercially available in the United States late this year.

"The approval of Surfaxin represents the first synthetic, peptide-containing surfactant product in the category," Thomas F. Miller, chief operating officer, Discovery Labs, told Formulary. "History has shown us that most therapeutic categories that begin with animal-derived medications ultimately evolve to new synthetic alternatives."

In addition, a recent independent, peer-reviewed study by Donn et. al. pointed toward a clear preference for synthetic alternatives to animal-derived medications by both neonatologists and parents of children in the NICU, according to Miller.

RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants.

Surfaxin is the fifth drug approved in the United States to treat RDS in premature infants. The other FDA-approved surfactants are beractant (Survanta, Abbott), poractant alpha (Curosurf, Chiesi Limited), and calfactant (Infasurf, Ony), and colfosceril palmitate (Exosurf, Glaxo Wellcome), which is no longer marketed.

The safety and efficacy of Surfaxin for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1,294 patients. Within 30 minutes of birth, infants in the study received either Surfaxin, Exosurf, or Survanta. Surfaxin and Exosurf served as the primary comparison for this study; Survanta served as another comparison. Surfaxin demonstrated significant improvement in both RDS at 24 hours after birth and RDS-related mortality through 2 weeks, when compared with Exosurf.

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 RDS.