FDA OKs Lucinactant for Respiratory Distress Syndrome in Premature Infants

Disclosures

March 06, 2012

Updated March 6, 2012 — The US Food and Drug Administration (FDA) today approved the first synthetic peptide-containing surfactant to prevent respiratory distress syndrome (RDS) in premature infants, giving clinicians an alternative to currently approved animal-derived surfactants, the drug's manufacturer announced.

The synthetic surfactant is lucinactant (Surfaxin, Discovery Laboratories). The company first asked the FDA to approve the drug for RDS in preemies in 2004. Today's green light from the agency represents its fifth pass on the application.

According to Discovery Laboratories, the lengthy approval process primarily stemmed from having to address FDA concerns about manufacturing as opposed to clinical efficacy.

RDS is a common breathing disorder among premature infants born 6 weeks or more before their due date. Such infants produce an insufficient amount of their own pulmonary surfactant, which coats the insides of their lungs and helps keep them open to enable breathing after birth. Lucinactant mimics the properties of human pulmonary surfactant.

Lucinactant joins 4 other surfactants approved to prevent RDS in premature infants — beractant (Survanta), poractant alpha (Curosurf), calfactant (Infasurf), and colfosceril palmitate (Exosurf), which is no longer marketed.

The FDA said in its announcement today that the drug's safety and efficacy were demonstrated by a single randomized, active-controlled, multi-dose study involving almost 1,300 premature infants who received either lucinactant, beractant, or colfosceril palmitate within 30 minutes of birth. The study primarily compared lucinactant and colfosceril palmitate, Lucitactant "demonstrated significant improvement in both RDS at 24 hours after birth and RDS-related mortality through 2 weeks" compared with colfosceril palmitate, the agency stated.

The most common adverse reaction with lucinactant involved the drug's administration through an endotracheal tube and included tube reflux and obstruction, pale skin, and dose interruption.

Roughly 90,000 premature infants in the United States each year are treated with animal-derived surfactants, according to Discovery Laboratories.

The company expects lucinactant to become commercially available late this year, according to a press release.

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