“The clinical implications of this research are important for many reasons,” said Rangasamy Ramanathan, M.D., F.A.A.P., lead author and Associate Division Chief of the Division of Neonatal Medicine at LAC+USC Medical Center and Children’s Hospital Los Angeles. “This is the first direct comparison between all three products and the largest, retrospective study with surfactants to date. This information is critical in neonatal intensive care units (NICUs) as we work to stabilize and improve outcomes in preterm infants who are struggling with RDS.”

Limitations of this retrospective study include database restrictions, such as lack of information on the precise cause of death, number of surfactant doses and antenatal steroid use.

This study was sponsored by Chiesi Farmaceutici S.p.A.

Indication

CUROSURF ® Intratracheal Suspension is indicated for the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF ® Intratracheal Suspension reduces mortality and pneumothoraces associated with RDS.

Important Safety Information

CUROSURF is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF, CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified in response to respiratory changes.

CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants.

TRANSIENT ADVERSE EFFECTS SEEN WITH THE ADMINISTRATION OF CUROSURF INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHAEL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.

Please see full prescribing information at www.curosurf.com .
 

References
1. National Vital Statistics Reports (2009, March 18). Vol. 57, (12, p. 14)

2. National Heart Lung and Blood Institute (2009, September 01). What is Respiratory Distress Syndrome? Retrieved August 30, 2011, from http://www.nhlbi.nih.gov/health/health-topics/topics/rds
 

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (Nasdaq: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products for the respiratory, hospital and related specialty markets. Key elements of the Company’s strategy are to focus on identifying therapeutic niches within respiratory, hospital and related specialty markets to leverage existing business and create new opportunities; promote the Company’s current products to high prescribing physicians through the Company’s respiratory sales force and to hospital-based healthcare professionals through the Company’s hospital sales force; license or acquire rights to existing patent- or trade secret-protected, branded products, which can be promoted through the same channels to generate on-going high-value earnings streams; advance the Company’s development projects and further build a robust pipeline; and generate revenues by marketing approved generic products through the Company’s wholly owned subsidiary, Aristos Pharmaceuticals, Inc.

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