Lucinactant (Discovery Laboratories)

Discovery Laboratories Inc (formerly Acute Therapeutics Inc (ATI) is developing lucinactant, originally identified at the Scripps Research Institute and sublicensed from Johnson & Johnson, for the potential treatment of respiratory diseases [174059], [357077], [361765], [422819]. The company anticipated filing an NDA for lucinactant in 2002, and by March 2002, lucinactant was in two pivotal phase III international trials for respiratory distress syndrome (RDS) in premature infants, a phase III trial for meconium aspiration syndrome (MAS) in full-term infants, and a phase II trial for acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in adults. The company expected to complete trials by late 2003 [400846], [445166]. In February 2002, lucinactant was awarded Orphan Drug product designation in Europe for the treatment of ALI, which incorporates ARDS [440083]. By April 2001, Orphan Drug status in the US had been granted for lucinactant for MAS [301112], RDS and ARDS [404160]. The FDA also designated the drug a Fast Track product for the treatment of MAS [302120] and ARDS [301562], [302176], [404160].