Overview
Beractant is a pulmonary surfactant used for the treatment of Respiratory Distress Syndrome (RDS) in premature infants. Considered a natural source of surfactant as it is made from bovine lung extract, beractant contains a mixture of phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins such as SP-B and SP-C. The final composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. In anticipation of birth, endogenous lung surfactant is produced to lower the surface tension on alveolar surfaces and to stabilize the alveoli against collapse at resting transpulmonary pressures. However, in Respiratory Distress Syndrome, developmental deficiency of surfactant results collapse of the alveoli causing fast breathing, increased heart rate, apoxia, and sometimes death. Administration of lung surfactant remains the cornerstone of therapy in this condition that is currently the leading cause of death in preterm infants. In comparison to synthetic forms of surfacant, natural forms such as Beractant have been found to have a reduced incidence of pneumothorax and reduced mortality.
Indication
Beractant is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants.
Associated Conditions
- Respiratory Distress Syndrome
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2016/05/17 | Phase 2 | UNKNOWN | Ramesh K Agarwal | ||
2013/09/13 | Phase 4 | Completed | Poznan University of Medical Sciences | ||
2013/05/22 | Not Applicable | Completed | Dr. Sami Ulus Children's Hospital | ||
2013/05/13 | Not Applicable | Completed | Dr. Sami Ulus Children's Hospital | ||
2012/02/23 | Not Applicable | Withdrawn | |||
2010/09/16 | Phase 2 | Completed | NICHD Neonatal Research Network | ||
2008/10/06 | Phase 4 | Terminated | Alan Fujii |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AbbVie Inc. | 0074-1040 | ENDOTRACHEAL | 25 mg in 1 mL | 2/29/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
SURVANTA beractant (as phospholipids) 200mg/8mL suspension vial | 48406 | Medicine | A | 3/18/1994 |
Help Us Improve
Your feedback helps us provide better drug information and insights.