An investigational d-amphetamine prodrug appears to be effective in treating pediatric attention deficit hyperactivity disorder with the goal of less abuse potential than amphetamines. All dose levels of lisdexamfetamine (NRP104) were significantly more effective than the placebo. The result of a phase III study was presented at the American Academy of Child and Adolescent Psychiatry meeting.
The study included 290 patients aged six to 12 with a primary diagnosis of ADHD. The participants were randomized to receive 30 mg, 50 mg, or 70 mg daily or placebo for four weeks followed by a 30 day observation period. Researchers concluded that those who received the drug were much improved than those who received the placebo.
Adverse events were consistent with what has been seen with other amphetamines. No serious adverse events were reported and most were mild or moderate in severity. The study was supported by New River Pharmaceuticals, which developed the drug, and Shire, which will market it. (Med Page)