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].