Clinical Profile of CUROSURF

Discover how CUROSURF provides fast RDS success. In addition to efficient administration, efficacy during the acute treatment phase is a critically important feature of a surfactant. Rapidly improved oxygenation, sustained efficacy, and fewer doses can all help wean infants to less invasive forms of ventilation.

See the data:

checkered flag

Onset

CUROSURF improves oxygenation within 5 minutes and rapidly reduces FiO2 requirements over the initial treatment period—delivering better short-term efficacy.1,2

Physiological end points (eg, faster reduction in FiO2) have not been proven to impact key clinical outcomes such as mortality due to RDS.

Faster reduction in FiO2 requirements vs Survanta® (beractant)3*

Faster reduction graph - see image description

P<0.05 at all post-treatment time points.

*Primary endpoint was FiO2 AUC0-6 defining onset of clinical response.

FiO2 = fraction of inspired oxygen.

Adapted from Ramanathan R, et al. Am J Perinatol. 2004;21:109-119.

CUROSURF improves oxygenation within 5 minutes1,2†

It has been suggested that faster oxygenation supports the treatment goal of weaning infants from mechanical ventilation more rapidly3

Oxygenation graph - see image description

Physiological end points (eg, faster reduction in FiO2) have not been proven to impact key clinical outcomes such as mortality due to RDS

P<0.001.

§P<0.01.

P<0.05.

a/A PO2 = arterial to alveolar oxygen tension ratio.

Adapted from Speer CP, et al. Arch Dis Child Fetal Neonatal Ed. 1995;72:F8-F13. Results from an open-label study. No short-term end points related to oxygenation were defined.

  • Study patients received rescue surfactant and mechanical ventilation as primary intervention. Early rescue INSURE technique not evaluated
  • 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 to respond to respiratory changes
Vial

Dosing

In clinical studies, most infants required only one dose of CUROSURF, which may reduce complications associated with reintubation and subsequent mechanical ventilation (MV).3,4

Clinical studies have not established that fewer doses result in superior safety or efficacy based on clinically relevant end points.

Single-dose success demonstrated across multiple studies3,5,6

Limited need to redose may decrease the risks associated with reintubation and MV3

Single-dose graph- see image description

#Gestational age.

Sustained results with fewer doses

CUROSURF demonstrates consistent FiO2 reductions sustained over time7:


Differences in FiO2 over 48 hours vs Survanta (beractant)7||

  • In a clinical trial, oxygen requirements did not rebound above redosing threshold (FiO2 ≥0.30) after first dose of CUROSURF during the first 48 hours7
  • Sustained reduction of FiO2 levels over 48 hours may reduce the need for redosing7
Sustained results graph - see image description

P=0.018 over first 48 hours.

||Shading indicates FiO2 range in which redosing was required.

FiO2 = fraction of inspired oxygen.

Adapted from Malloy CA, et al. Acta Paediatr. 2005;94:779-784. (N=58)



Reductions in respiratory index over the first 3 days of life vs Survanta8

In a clinical trial, infants required lower respiratory support for the first 72 hours of life vs Survanta8

Reduction in respiratory graph - see image description

P=0.032 over first 72 hours.

MAP = mean airway pressure.

Adapted from Fujii AM, et al. J Perinatol. 2010;30:665-670.

  • Lower respiratory requirements in the CUROSURF group could be attributed to a greater number of infants extubated at 48 and 72 hours vs Survanta8
  • Physiological end points (eg, faster reductions in FiO2) have not been proven to impact key clinical outcomes such as mortality due to RDS
Arrows pointing down

Volume

CUROSURF delivers more surfactant with less volume9**,††

Initial dose delivers a higher concentration of surfactant at a lower volume vs other exogenous surfactants.10-14 Less volume may improve tolerability and has the potential to reduce complications such as airway obstruction.9

CUROSURF delivers more surfactant with less volume10-14

  • Initial dose delivers a higher concentration of surfactant at a lower volume vs other exogenous surfactants10-14
  • Less volume may improve tolerability and has the potential to reduce complications such as airway obstruction10-14
Volume graph - see image description

**Clinical studies have not established that lower volume results in superior efficacy or safety based on clinically relevant end points10-13
††While clinical studies have demonstrated that phospholipids are an essential element, they have not established the quantity required for optimal surfactant efficacy10-13
‡‡The initial recommended dose of CUROSURF is 2.5 mL/kg birth weight. Up to 2 repeat doses of 1.25 mL/kg birth weight each may be administered at approximately 12‑hour intervals. A total of 4 doses of Survanta (4 mL/kg birth weight) can be administered no more frequently than every 6 hours in the first 48 hours of life. Infasurf (3 mL/kg birth weight) can be administered every 12 hours, up to a total of 3 doses.
§§Based on a 1000-g infant and manufacturer’s dosing schedule. Volume of surfactant is measured in millimeters per kilogram of body weight at birth.

Distribution

CUROSURF spreads fast and evenly for smooth instillation15¶¶


Control lamb: distribution in first 4 minutes

  • Quickly forms a stable surfactant monolayer inside alveoli16
  • Suctioning of airways permitted after 1 hour10
Distribution graphic - see image description

¶¶Unpublished photos presented during the 15th International Workshop on Surfactant Replacement, 2000.

  • Preclinical data may not be predictive of clinical results



CUROSURF is a thin suspension that demonstrates a low reflux rate and fast recovery time after administration9

  • In an open-label, observational study, CUROSURF demonstrated relatively quick administration and rapid recovery within 1 minute.9 In addition, CUROSURF demonstrated a low reflux rate, which may improve tolerability and ease of administration9
  • It has been suggested that the thin suspension may help minimize airway and endotracheal tube obstruction and associated complications such as transient hypercapnia9,17

3.5% reflux rate 5-15 min after administration (9).81% of babies recovered within 1 min (9).

Adapted from Gerdes JS, et al. J Pediatr Pharmacol Ther. 2006;11:92-100.

##It is important to note that the INSURE strategy may not be appropriate for all infants. Infants with RDS may vary markedly in the severity of respiratory disease, maturity, and presence of other complications, and thus it is necessary to individualize patient care.

IMPORTANT SAFETY INFORMATION

CUROSURF® (poractant alfa) 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 to respond to respiratory changes.

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

Transient adverse reactions associated with administration of CUROSURF include bradycardia, hypotension, endotracheal 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.

Pulmonary hemorrhage, a known complication of premature birth and very low birth-weight, has been reported with CUROSURF. The rates of common complications of prematurity observed in a multicenter single-dose study that enrolled infants 700–2000 g birth weight with RDS requiring mechanical ventilation and FiO2 ≥ 0.60 are as follows for CUROSURF 2.5 mL/kg (200 mg/kg) (n=78) and control (n=66; no surfactant) respectively: acquired pneumonia (17% vs. 21%), acquired septicemia (14% vs. 18%), bronchopulmonary dysplasia (18% vs. 22%), intracranial hemorrhage (51% vs. 64%), patent ductus arteriosus (60% vs. 48%), pneumothorax (21% vs. 36%) and pulmonary interstitial emphysema (21% vs. 38%).

INDICATION

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

Please see Full Prescribing Information.

References: 1. Speer CP, Gefeller O, Groneck P, et al. Arch Dis Child. 1995;72:F8-F13. 2. Collaborative European Multicenter Study Group. Pediatrics. 1988;82:683-691. 3. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K; And The North American Study Group. Am J Perinatol. 2004;21:109-119. 4. Verder H, Albertsen P, Ebbesen F, et al. Pediatrics. 1999;103:1-6. 5. Dizdar EA, Sari FN, Aydemir C, et al. Am J Perinatol. 2012;29:95-100. 6. Karadag N, Dilli D, Zenciroglu A, Aydin B, Beken S, Okumus N. Am J Perinatol. 2014;31:1015-1022. 7. Malloy CA, Nicoski P, Muraskas JK. Acta Pediatr. 2005;94:779-784. 8. Fujii AM, Patel SM, Allen R, et al. J Perinatol. 2010;30:665-670. 9. Gerdes JS, Seiberlich W, Sivieri EM, et al. J Pediatr Pharmacol Ther. 2006;11:92-100. 10. CUROSURF® (poractant alfa) Intratracheal Suspension Prescribing Information, Chiesi USA, Inc. May 2021. 11.Survanta® (beractant) Intratracheal Suspension Prescribing Information, AbbVie, Inc. October 2020. 12. Infasurf® (calfactant) Intratracheal Suspension Prescribing Information, ONY, Inc, March 2018. 13. Moya FR, Gadzinowski J, Bancalari E, et al. Pediatrics. 2005;115:1018-1029. 14. Sinha SK, Lacaze-Masmonteil T, Valls I, et al. Pediatrics. 2005;115:1030-1038. 15. Ingimarsson J, Björklund L, Jonson B, et al. Biol Neonate. 2000;77(suppl 1):24. 16. Schürch S, Schürch D, Curstedt T, Robertson B. J Appl Physiol. 1994;77:974-986. 17. Wiseman IR, Bryson HM. Drugs. 1994;48:386-403.