Abstract

Lisdexamfetamine dimesylate is a long-acting amfetamine prodrug that requires in vivo hydrolysis to gradually release active d-amfetamine. It is approved in the US for the treatment of attention-deficit hyperactivity disorder (ADHD) in adults and in children aged 6-12 years. In a study in adult stimulant abusers, oral lisdexamfetamine 50 or 100 mg showed less 'likability' response than immediate-release d-amfetamine 40 mg on the Drug Rating Questionnaire-Subject (DRQS) Liking scale. However, there was no significant difference between lisdexamfetamine 150 mg and d-amfetamine 40 mg. In a randomized, double-blind, phase III trial in adult patients with ADHD, oral lisdexamfetamine 30, 50 or 70 mg/day for 4 weeks caused a significantly greater improvement in ADHD-Rating Scale (ADHD-RS) total score than placebo; significant between-group differences favouring lisdexamfetamine were evident after 1 week. Lisdexamfetamine was generally well tolerated in adult patients with ADHD, with most treatment-emergent adverse events being of mild to moderate severity and consistent with the known effects of psychostimulants.