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news.Shire has reported European phase III positive results of its lisdexamfetamine dimesylate (LDX) to treat Attention-Deficit/Hyperactivity Disorder (ADHD).
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LDX is a chemically formulated long-acting prescription-only medicine, prodrug of dexamfetamine.
The active-controlled, double-blind, dose-optimisation, parallel-group, multicentre, randomised study, which enrolled 336 children and adolescents aged 6 to17 with ADHD, was designed to study the safety and efficacy of lisdexamfetamine dimesylate.
Patients received daily morning dose of either 30, 50, and 70mg/day for LDX and18, 36, and 54mg for OROS-MPH , or placebo.
The study, conducted at 48 sites across Europe, demonstrated that LDX met efficacy on the primary and key secondary measures compared to placebo, and a safety profile consistent with the known effects of amfetamine treatment and previous LDX trials.