SURFAXIN®

Discovery Labs' first product based on KL4 Surfactant technology is SURFAXIN® (lucinactant), a liquid instillate formulation targeting Respiratory Distress Syndrome (RDS). Discovery Labs has received a Complete Response for SURFAXIN® from the US FDA for the prevention of RDS in premature infants. Please see our latest press release for more information on the regulatory status of SURFAXIN®.

SURFAXIN® has demonstrated clinically meaningful survival and morbidity-lessening advantages versus comparator surfactants (the current standard of care) in two Phase 3 clinical trials, SELECT and STAR.

The SELECT (Safety and Effectiveness of Lucinactant vs. Exosurf in a Clinical Trial) trial was Discovery Labs' pivotal Phase 3 RDS prevention trial that enrolled 1294 patients. It was designed as a multinational, multi-center, randomized trial to demonstrate the safety and efficacy of SURFAXIN® in comparison with Exosurf®, an approved, non-protein containing synthetic surfactant. Survanta®, an animal-derived surfactant that is a US market leader served as a reference arm. An independent Data Safety Monitoring Board (DSMB) was responsible for monitoring the overall safety of the trial. Additionally, all key endpoints were fully adjudicated by a blinded panel of internationally recognized neonatology experts. Key results from the SELECT trial can be summarized as follows:

  • SURFAXIN® demonstrated a significant improvement in RDS related mortality profile through 14 days of life vs. Survanta (p ≤ .001) & Exosurf (p ≤ .01). 39
  • SURFAXIN® demonstrated a significant (p ≤ .01) improvement in RDS at 24 hours of life vs. Exosurf. No significant difference versus Survanta was observed. 39
  • SURFAXIN® significantly (p ≤ .05) improved survival without BPD and overall incidence of BPD vs. Exosurf. 39
  • SURFAXIN® treated infants required significantly fewer (p ≤ .05) re-intubations (insertion of endotracheal tube into the airway) vs. Survanta. 38
  • SURFAXIN®, in a pharmacoeconomic assessment, demonstrated a reduction in total NICU days and patient days on ventilator vs. Survanta. 42
  • SURFAXIN® was generally safe and well tolerated. 39

The STAR (SURFAXIN® Therapy Against RDS) trial was a supportive, multinational, multi-center Phase 3 clinical trial enrolling 252 patients and was designed as a non-inferiority trial comparing SURFAXIN® with Curosurf®, a porcine (pig) derived surfactant and the leading surfactant used in Europe. Key results from the STAR trial can be summarized as follows:

  • SURFAXIN® was non-inferior to Curosurf in survival without BPD (numerical treatment difference = 4.7% favoring SURFAXIN® vs. Curosurf). 40
  • Survival profile through one year of life (corrected age) was significantly improved in SURFAXIN® treated infants (p ≤ .05) vs. Curosurf. 40
  • SURFAXIN® treated infants required significantly fewer (p ≤ .05) re-intubations vs. Curosurf. 40 0
  • SURFAXIN® was generally safe and well tolerated. 40

The data from the SELECT and STAR trial formed the basis for the SURFAXIN® New Drug Application (NDA) which is currently being reviewed by the FDA. These trials were published in the April, 2005 issue of Pediatrics, the most relevant peer-reviewed and internationally recognized medical journal in this category. 39 40 The FDA granted Discovery Labs Orphan Drug designation for SURFAXIN® for the treatment of RDS in premature infants, and the EMEA granted Discovery Labs Orphan Drug designation for SURFAXIN® for the prevention and treatment of RDS in premature infants.

SURFAXIN® (lucinactant) is an investigational drug, not approved for use, and is the subject of a Complete Response Letter from the US Food & Drug Administration for the prevention of RDS in infants at high risk for RDS. Several published and presented pre-clinical and clinical studies are referenced throughout this website; however, approved and final prescribing information from the US Food & Drug Administration for Surfaxin is not available at this time.