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Lucinactant (Discovery Laboratories).

Ian Doyle1

  • 1Flinders University of South Australia, School of Medicine, Flinders Medical Centre, Bedford Park, South Australia, 5042, Australia. Ian.Doyle@flinders.edu.au

Idrugs : the Investigational Drugs Journal
|June 13, 2003
PubMed
Summary
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Lucinactant is being developed for respiratory diseases like respiratory distress syndrome and acute lung injury. This drug has received Orphan Drug and Fast Track designations in the US and Europe.

Area of Science:

  • Pulmonary Medicine
  • Pharmacology

Background:

  • Discovery Laboratories Inc. is developing lucinactant, a potential treatment for various respiratory diseases.
  • The drug was originally identified at the Scripps Research Institute and sublicensed from Johnson & Johnson.

Purpose of the Study:

  • To evaluate lucinactant's efficacy and safety in treating respiratory distress syndrome (RDS) in premature infants.
  • To assess lucinactant for meconium aspiration syndrome (MAS) in full-term infants.
  • To investigate lucinactant for acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in adults.

Main Methods:

  • Two pivotal international phase III trials for RDS.
  • One phase III trial for MAS.
  • One phase II trial for ALI/ARDS.

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Main Results:

  • Lucinactant was in late-stage clinical trials by March 2002, with completion anticipated by late 2003.
  • Received Orphan Drug designation in Europe for ALI (including ARDS) in February 2002.
  • Received US Orphan Drug status for MAS, RDS, and ARDS by April 2001.
  • Granted FDA Fast Track designation for MAS and ARDS.

Conclusions:

  • Lucinactant demonstrated potential for treating severe respiratory conditions in both premature and full-term infants, as well as adults.
  • Regulatory designations (Orphan Drug, Fast Track) underscore the potential clinical significance of lucinactant for unmet medical needs in respiratory diseases.