Cephalon’s Sparlon was associated with 31 cases of suicidality, aggression or psychosis in clinical trials for attention deficit hyperactivity disorder in children, FDA reported in a summary for its Pediatric Advisory Committee, which is set to meet on this week, on March 22, 2006.
An analysis provided by Cephalon as part of its response to FDA’s Oct. 20 “approvable” letter for the ADHD indication found four suicidal events, two events of psychosis/mania and nine aggression events in the double blind clinical studies of Sparlon (modafinil).
You can read more on the FDA site here.
