Curosurf Offers Rapid Onset of Action and Reduced Frequency of Dosing in the Treatment of Respiratory Distress Syndrome in Preterm Infants.

Business Editors/Health & Medical Writers

BALTIMORE--(BW HealthWire)--May 6, 2002

Clinical Trial Results Presented at Pediatric Academic Societies'

Annual Meeting

In a study presented Sunday at the Pediatric Academic Societies Annual Meeting, Curosurf(R)(poractant alfa) Intratracheal Suspension was effective in the treatment of neonatal respiratory distress syndrome (RDS) in preterm infants when compared to Survanta(R) (beractant) Intratracheal Suspension. These data also suggest that Curosurf offers a rapid onset of action and requires fewer doses than Survanta.

Dr. Rangasamy Ramanathan, Associate Professor of Pediatrics at the University of Southern California Keck Medical School and lead investigator and author of the trial, presented the results here during the Perinatal and Neonatal I Platform Session.

"These data suggest that Curosurf may offer a clinical advantage over Survanta in treating preterm infants with RDS," said Dr. Ramanathan. "Particularly when reducing time on assisted ventilation and supplemental oxygen is the goal of therapy, rapid improvement in oxygenation is critical in the treatment of RDS."

The randomized, multicenter masked trial compared the onset of clinical response of a 100 mg/kg initial dose of Curosurf with that of a 200 mg/kg initial dose of Curosurf or a 100 mg/kg initial dose of Survanta in 293 preterm infants with established neonatal RDS.(1) The onset of clinical response was studied by comparing the changes in the fraction of inspired oxygen between zero and six hours after the first dose of surfactant. In addition, the overall clinical outcomes at 28 days and 36 weeks postconceptional age were evaluated. The following results were reported:

-- Initial treatment with Curosurf 100 or 200 mg/kg was associated with faster
weaning of supplemental oxygen when compared to Survanta.

-- Infants treated with an initial dose of 200 mg/kg of Curosurf, followed by
100 mg/kg of Curosurf, showed a modest benefit in the acute phase of RDS.

-- Initial treatment with Curosurf 200 mg/kg was associated with significantly
decreased need for additional doses of surfactant compared to Survanta (27%
versus 49%).

-- Neonatal mortality was lowest in the 200 mg/kg Curosurf group (3%) as
compared to 6% and 8% in the 100 mg/kg Curosurf and Survanta groups
respectively.

Respiratory distress syndrome occurs in babies with incomplete lung development and is a common complication in premature infants. RDS is caused by insufficient surfactant in the lungs, a substance that keeps the lungs from collapsing, and allows the exchange of gases in the lungs. If not treated properly, RDS can lead to more serious complications and is one of the most common causes of neonatal mortality. There are approximately 50,000 infants at risk for RDS born each year in the United States.(2)

Curosurf can rapidly affect oxygenation and lung function in very low birth weight infants with RDS by supplying surfactant to the lungs. Curosurf is the most concentrated pulmonary surfactant available to clinicians, permitting smaller volume of dosing. In addition, Curosurf has the highest success rate with a single dose: one dose of 200 mg/kg of Curosurf is effective in 73% of infants treated.(1)

Treated infants should receive frequent clinical and laboratory assessments such that oxygen and ventilator support can be modified in response to rapid improvement in lung function. Transient adverse effects seen with the administration of Curosurf include bradycardia, endotracheal tube blockage and oxygen desaturation.

About Dey, L.P.

Dey, L.P., is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases and respiratory-related allergies. Since 1978, patients have benefited from Dey's commitment to innovative and affordable health care solutions. The web sites for Dey include www.deyinc.com, www.duoneb.com and www.epipen.com. Dey is an associate of Merck KGaA, Darmstadt, Germany.

(1) A randomized, multicenter masked comparison trial of Curosurf and

Survanta in the treatment of established neonatal respiratory

distress syndrome in preterm infants. Ramanthan R, Rasmussen MR,

Gerstmann D et al. Pediatr Res 2002.

(2) Lung Surfactants Basic Science and Clinical Applications, Vol.

149, 2000, Robert H. Notter.