Poractant Alfa (Curosurf): A Comprehensive Clinical Monograph

1.0 Executive Summary

Poractant alfa, marketed under the brand name Curosurf, is a life-saving biotech therapeutic agent classified as a natural pulmonary surfactant. It is derived from an extract of porcine lung tissue and is primarily indicated for the rescue treatment of Neonatal Respiratory Distress Syndrome (RDS) in premature infants, a condition caused by an endogenous surfactant deficiency. Its use is associated with a significant reduction in mortality and the incidence of pneumothoraces.[1]

The drug product is a complex mixture of approximately 99% polar lipids and 1% hydrophobic proteins, including the critical surfactant-associated proteins SP-B and SP-C.[4] A defining characteristic of its manufacturing is a liquid-gel chromatography purification step, which is unique among commercially available surfactants. This process removes neutral lipids, resulting in a final product with a high concentration of active phospholipids (80 mg/mL), allowing for the administration of a therapeutic dose in a lower volume compared to its competitors.[1]

The mechanism of action of Poractant alfa is to compensate for the surfactant deficiency in the premature lung. Administered directly via the intratracheal route, it rapidly adsorbs to the air-liquid interface of the alveoli, reducing surface tension and preventing alveolar collapse (atelectasis) at end-expiration.[5] The pharmacodynamic effects are immediate and profound, with marked improvements in oxygenation and lung compliance often observed within minutes of instillation. This necessitates vigilant monitoring and adjustment of ventilatory support by experienced clinicians.[9]